Trial Outcomes & Findings for A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias. (NCT NCT00315705)
NCT ID: NCT00315705
Last Updated: 2014-04-14
Results Overview
The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused \<= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 as taken by Cohort 5 was to become the RP2D. The rating scale used is 0 = not the MTD, 1 = the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to Day 42 (Phase 1 portion of study)
Results posted on
2014-04-14
Participant Flow
Participant milestones
| Measure |
Clofarabine, Etoposide, Cyclophosphamide
Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m\^2, etoposide dosage from 75-100 mg/m\^2, cyclophosphamide dosage from 340-440 mg/m\^2.\> Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously
|
|---|---|
|
Phase 1
STARTED
|
25
|
|
Phase 1
COMPLETED
|
0
|
|
Phase 1
NOT COMPLETED
|
25
|
|
Phase 2
STARTED
|
25
|
|
Phase 2
COMPLETED
|
0
|
|
Phase 2
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Clofarabine, Etoposide, Cyclophosphamide
Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m\^2, etoposide dosage from 75-100 mg/m\^2, cyclophosphamide dosage from 340-440 mg/m\^2.\> Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously
|
|---|---|
|
Phase 1
Refused further treatment
|
1
|
|
Phase 1
Failure to achieve response
|
8
|
|
Phase 1
Disease relapse
|
4
|
|
Phase 1
Scheduled for transplant
|
9
|
|
Phase 1
Death
|
3
|
|
Phase 2
Physician Decision
|
4
|
|
Phase 2
Adverse Event
|
1
|
|
Phase 2
Failure to achieve response
|
3
|
|
Phase 2
Disease relapse
|
1
|
|
Phase 2
Scheduled for transplant
|
8
|
|
Phase 2
Other
|
1
|
|
Phase 2
Death
|
7
|
Baseline Characteristics
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Baseline characteristics by cohort
| Measure |
Phase 1: Clofarabine, Etoposide, Cyclophosphamide
n=25 Participants
Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m\^2, etoposide dosage from 75-100 mg/m\^2, cyclophosphamide dosage from 340-440 mg/m\^2.
|
Phase 2: Clofarabine, Etoposide, Cyclophosphamide
n=25 Participants
Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 5.03 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 5.25 • n=7 Participants
|
11.2 years
STANDARD_DEVIATION 5.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Percent Leukemic Blast Cells
|
66.8 percentage of total blast cells
STANDARD_DEVIATION 24.85 • n=5 Participants
|
69.52 percentage of total blast cells
STANDARD_DEVIATION 23.566 • n=7 Participants
|
68.16 percentage of total blast cells
STANDARD_DEVIATION 24.008 • n=5 Participants
|
|
Absolute Neutrophil Counts
|
1.93828 10^9/L
STANDARD_DEVIATION 3.049992 • n=5 Participants
|
1.9280 10^9/L
STANDARD_DEVIATION 1.708126 • n=7 Participants
|
1.93325 10^9/L
STANDARD_DEVIATION 2.459536 • n=5 Participants
|
|
White Blood Cell Counts
|
8.323 10^9/L
STANDARD_DEVIATION 9.1305 • n=5 Participants
|
12.171 10^9/L
STANDARD_DEVIATION 23.0150 • n=7 Participants
|
10.247 10^9/L
STANDARD_DEVIATION 17.4370 • n=5 Participants
|
|
Immunophenotype
B cell
|
13 participants
n=5 Participants
|
21 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Immunophenotype
T cell
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Immunophenotype
Unknown
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Immunophenotype
not included (AML participants)
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Count of Previous Anti-Leukemic (non-transplant) Treatment Regimens
1 regimen
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Count of Previous Anti-Leukemic (non-transplant) Treatment Regimens
2 regimens
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Count of Previous Anti-Leukemic (non-transplant) Treatment Regimens
3 regimens
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Participants with Previous Anti-Leukemic Transplant Regimens
Transplants
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Participants with Previous Anti-Leukemic Transplant Regimens
No transplants
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Participants Who Were Refractory to the Most Recent Previous Anti-Leukemic Treatment
Yes
|
7 participants
n=5 Participants
|
15 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Participants Who Were Refractory to the Most Recent Previous Anti-Leukemic Treatment
No
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
50
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
60
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
70
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
80
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
90
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Participant Rating Using the Karnofsky/Lansky Performance Status Scale
100
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42 (Phase 1 portion of study)Population: All phase 1 participants
The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused \<= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 as taken by Cohort 5 was to become the RP2D. The rating scale used is 0 = not the MTD, 1 = the MTD.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
n=10 Participants
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
n=6 Participants
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) in Phase 1
|
0 units on a scale
|
0 units on a scale
|
0 units on a scale
|
0 units on a scale
|
0 units on a scale
|
PRIMARY outcome
Timeframe: Up to Day 42 (Phase 1 portion of study)Population: All phase 1 participants
The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
n=10 Participants
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
n=6 Participants
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Participants With Dose Limiting Toxicity in Phase 1
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Approximately 28-56 days (Phase 2 portion of study)Population: All phase 2 participants
Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with \<5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 \[x 10\^9/L\] 2) CR in absence of plt recovery (CRp): plt ≥20 to \<75 x 10\^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with \<5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Overall remission (OR)
|
44 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Any response (CR+CRp+PR)
|
56 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Complete remission (CR)
|
28 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Complete remission/absence total platelet recovery
|
16 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2
Partial remission (PR)
|
12 percentage of total participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 9.5 months (Phase 1 portion of study)Population: All phase 1 participants
Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) and relationship to study drug. The severity scale is:\> Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
n=3 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
n=10 Participants
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
n=6 Participants
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
AE with the worst grade of: 3
|
2 participants
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
AE with the worst grade of: 4
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
2 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
AE with the worst grade of: 5
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
AE with the worst grade of: 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
AE with the worst grade of: 2
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
At least one AE
|
3 participants
|
3 participants
|
3 participants
|
10 participants
|
6 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
At least one AE related to clofarabine
|
3 participants
|
3 participants
|
3 participants
|
10 participants
|
6 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
At least one serious AE
|
3 participants
|
3 participants
|
3 participants
|
9 participants
|
6 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
At least one serious AE related to clofarabine
|
3 participants
|
2 participants
|
3 participants
|
9 participants
|
5 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
Discontinued study due to AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Participants With Adverse Events (AEs) in Phase 1
Died
|
3 participants
|
1 participants
|
3 participants
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Approximately 2 months (Phase 1 portion of study)Population: All phase 1 participants
Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with \<5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 \[x 10\^9/L\]; AML ≥100/ ≥1.0 \[x 10\^9/L\] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to \<75 x 10\^9/L; AML plt ≥20 to \<100 x 10\^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with \<5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Complete remission (CR)
|
40 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Complete remission/absence total platelet recovery
|
24 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Partial remission (PR)
|
0 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Overall remission (OR)
|
64 percentage of total participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1
Any response (CR+CRp+PR)
|
64 percentage of total participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 8 weeks (Phase 1 portion of study)Population: Participants in phase 1 who had an overall remission.
The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=16 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Time to Remission for Participants Who Had a Response in Phase 1
|
4.96 weeks
Standard Deviation 1.912
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 1 portion of study)Population: Phase 1 participants who achieved overall remission. Data are censored at date of last known follow-up visit.
Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=16 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1
|
18.2 weeks
Interval 12.9 to 35.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 1 portion of study)Population: All phase 1 participants. Data are censored at date of last known follow-up visit.
Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1
|
19.3 weeks
Interval 12.7 to 27.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 months (Phase I portion of study)Population: All participants
Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Number of Participants With 4-month Event Free Survival in Phase 1
|
13 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 1 portion of study)Population: All phase 1 participants
Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1
|
27.1 weeks
Interval 18.3 to 42.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 9.5 months (Phase 2 portion of study)Population: All phase 2 participants
Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) and relationship to study drug. The severity scale is:\> Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
Died
|
16 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
At least one AE
|
25 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
At least one AE related to clofarabine
|
25 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
At least one serious AE
|
21 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
At least one serious AE related to clofarabine
|
20 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
Discontinued study due to AE
|
1 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
AE with the worst grade of: 1
|
0 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
AE with the worst grade of: 2
|
0 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
AE with the worst grade of: 3
|
1 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
AE with the worst grade of: 4
|
16 participants
|
—
|
—
|
—
|
—
|
|
Summary of Participants With Adverse Events (AEs) in Phase 2
AE with the worst grade of: 5
|
8 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 8 weeks (Phase 2 portion of study)Population: Participants in phase 2 who had an overall remission.
The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=11 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Time to Remission for Participants Who Had a Response in Phase 2
|
4.84 weeks
Standard Deviation 2.092
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 2 portion of study)Population: Phase 2 participants who achieved overall remission. Data are censored at date of last known follow-up visit.
Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=11 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2
|
67.3 weeks
Interval 13.4 to
NA = not estimable because values are mostly censored. Participants with longer DORs have not relapsed, progressed, or died, therefore the upper confidence limit cannot be estimated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 2 portion of study)Population: All phase 2 participants. Data are censored at date of last known follow-up visit.
Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2
|
10.7 weeks
Interval 6.7 to 73.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 months (Phase 2 portion of study)Population: All participants
Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Number of Participants With 4-month Event Free Survival in Phase 2
|
11 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years (Phase 2 portion of study)Population: All phase 2 participants. Data are censored at date of last known follow-up visit.
Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.
Outcome measures
| Measure |
Phase 1 - Cohort 1
n=25 Participants
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
|---|---|---|---|---|---|
|
Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2
|
10.7 weeks
Interval 8.1 to 38.6
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 - Cohort 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 - Cohort 2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 - Cohort 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 - Cohort 4
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 1 - Cohort 5
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 - Total
Serious events: 24 serious events
Other events: 25 other events
Deaths: 0 deaths
Phase 2: Clofarabine, Etoposide, Cyclophosphamide
Serious events: 21 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 - Cohort 1
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
n=10 participants at risk
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
n=6 participants at risk
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Total
n=25 participants at risk
All participants from Cohorts 1-5 in Phase 1
|
Phase 2: Clofarabine, Etoposide, Cyclophosphamide
n=25 participants at risk
Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
70.0%
7/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
68.0%
17/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
15/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Intracardiac mass
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Trichiasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Chills
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
BK virus infection
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Central nervous system infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Cerebral fungal infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Ear infection fungal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Meningitis streptococcal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Otitis media bacterial
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Viraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Fungal test positive
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Polyomavirus test positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
Other adverse events
| Measure |
Phase 1 - Cohort 1
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2.
|
Phase 1 - Cohort 2
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 3
n=3 participants at risk
Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 4
n=10 participants at risk
Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Cohort 5
n=6 participants at risk
Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2.
|
Phase 1 - Total
n=25 participants at risk
All participants from Cohorts 1-5 in Phase 1
|
Phase 2: Clofarabine, Etoposide, Cyclophosphamide
n=25 participants at risk
Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
64.0%
16/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
52.0%
13/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
5/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
44.0%
11/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
64.0%
16/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Ear and labyrinth disorders
Mixed deafness
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Ectropion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Eye haemorrhage
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Retinopathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
90.0%
9/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
52.0%
13/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
40.0%
4/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
36.0%
9/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
70.0%
7/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
83.3%
5/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
68.0%
17/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
90.0%
9/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
83.3%
5/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
84.0%
21/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
80.0%
20/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Pancreatic atrophy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
90.0%
9/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
6/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
88.0%
22/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
88.0%
22/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Application site rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Catheter site rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Bacterial test positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Chills
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Device occlusion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Irritability
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Pneumatosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Puncture site pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
70.0%
7/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
83.3%
5/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
15/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
52.0%
13/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
BK virus infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Herpes zoster multi-dermatomal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Otitis media
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
32.0%
8/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Antimicrobial susceptibility test sensitive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
44.0%
11/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood amylase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Culture stool positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Fungal test positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Occult blood positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Polyomavirus test positive
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Specific gravity urine abnormal
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Specific gravity urine increased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Urine ketone body
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
5/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
4/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
48.0%
12/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
15/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
6/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
44.0%
11/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
15/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
32.0%
8/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
5/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
44.0%
11/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile wart
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
40.0%
4/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
70.0%
7/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
4/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
56.0%
14/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
36.0%
9/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
40.0%
4/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
40.0%
10/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Kidney enlargement
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
100.0%
3/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
28.0%
7/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
3/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
5/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
20.0%
2/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Acanthosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
30.0%
3/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
12.0%
3/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
5/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
32.0%
8/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
24.0%
6/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
60.0%
6/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
4/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
56.0%
14/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.0%
4/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
16.7%
1/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
4.0%
1/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
1/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
10.0%
1/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
8.0%
2/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
0.00%
0/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
66.7%
2/3 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
50.0%
5/10 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
33.3%
2/6 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
36.0%
9/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
44.0%
11/25 • Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
|
Additional Information
Genzyme Medical Information
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Phone: 1-800-745-4447
Results disclosure agreements
- Principal investigator is a sponsor employee In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
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