Trial Outcomes & Findings for A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB (NCT NCT01125800)
NCT ID: NCT01125800
Last Updated: 2017-03-20
Results Overview
DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC \<1.0x10\^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets \<50x10\^9/L); ≥ CTCAE grade 3 anemia (Hgb \<80 g/L); Febrile neutropenia (ANC \<1x10\^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (\>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (\>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (\>1.5ULN) together with ≥ grade 3 ALT elevation (\>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline, End of dose escalation part (Day 42)
Results posted on
2017-03-20
Participant Flow
The study was conducted at 14 centers in 6 countries.
A total of 76 participants: 60 pediatric and 16 adult participants were enrolled in this study, of which 59 pediatric participants received sonidegib during the dose-escalation and expansion part (Phase I); 17 participants (1 child and 16 adults) received sonidegib in the Phase II.
Participant milestones
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Phase I
STARTED
|
11
|
16
|
11
|
21
|
0
|
|
Phase I
COMPLETED
|
3
|
7
|
7
|
10
|
0
|
|
Phase I
NOT COMPLETED
|
8
|
9
|
4
|
11
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
1
|
16
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
1
|
11
|
Reasons for withdrawal
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Phase I
Protocol Violation
|
0
|
3
|
1
|
1
|
0
|
|
Phase I
Adverse Event
|
2
|
2
|
1
|
7
|
0
|
|
Phase I
Administrative problems
|
1
|
0
|
0
|
0
|
0
|
|
Phase I
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Phase I
Disease progression
|
5
|
4
|
1
|
3
|
0
|
|
Phase II
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Phase II
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Phase II
Disease progression
|
0
|
0
|
0
|
1
|
8
|
Baseline Characteristics
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB
Baseline characteristics by cohort
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
n=16 Participants
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
≤ 10 years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
0 participants
n=21 Participants
|
23 participants
n=8 Participants
|
|
Age, Customized
>10 years to 17 years
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
6 participants
n=5 Participants
|
11 participants
n=4 Participants
|
0 participants
n=21 Participants
|
37 participants
n=8 Participants
|
|
Age, Customized
18-65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
16 participants
n=21 Participants
|
16 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of dose escalation part (Day 42)Population: The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.
DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC \<1.0x10\^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets \<50x10\^9/L); ≥ CTCAE grade 3 anemia (Hgb \<80 g/L); Febrile neutropenia (ANC \<1x10\^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (\>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (\>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (\>1.5ULN) together with ≥ grade 3 ALT elevation (\>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT) in Phase I
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, End of dose escalation part (Day 42)Population: The MTD for the pediatric population was not established in this study. MTD was not achieved since 1 or no DLT was observed. The recommended phase II dose was established based on the safety, pharmacokinetics, and clinical responses observed.
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=60 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use
|
680 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)Population: The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.
The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=60 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR) by Treatment
Complete response
|
3.3 Percentage of participants
|
12.5 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate (ORR) by Treatment
Partial response
|
0 Percentage of participants
|
6.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate (ORR) by Treatment
Stable disease
|
8.3 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate (ORR) by Treatment
Progressive disease
|
76.7 Percentage of participants
|
37.5 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate (ORR) by Treatment
Objective response rate
|
3.3 Percentage of participants
|
18.8 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (start of study treatment) up to End of treatment (Within 14 days of last dose)Population: The analysis was performed in safety set (SS), defined as all the participants who received at least 1 dose of sonidegib.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. On-treatment deaths were deaths which occurred up to 30 days after last date of study treatment.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
n=16 Participants
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study
AEs
|
11 participants
|
16 participants
|
11 participants
|
22 participants
|
16 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study
AEs suspected to be drug related
|
8 participants
|
13 participants
|
9 participants
|
14 participants
|
13 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study
AEs leading to discontinuation
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study
On-treatment deaths
|
2 participants
|
2 participants
|
1 participants
|
8 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study
SAEs
|
5 participants
|
8 participants
|
4 participants
|
14 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1Population: The analysis was performed in pharmacokinetic analysis set (PAS), defined as all the participants who received at least one (full or partial) dose of sonidegib and provided at least one evaluable pharmacokinetic (PK) blood sample. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
AUC(0-24h) was defined as the area under the drug concentration time curve calculated using linear trapezoidal summation from time zero to 24 hours after dosing.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I
Cycle 1/Day 1 (n=11, 15, 11, 19)
|
1981.56 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 736.928
|
2194.29 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 1592.396
|
5309.44 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 3247.088
|
5117.61 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 2658.133
|
—
|
|
Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I
Cycle 1/Day 22 (n=9, 14, 9, 15)
|
10589.53 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 4163.192
|
15431.43 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 10433.35
|
17753.32 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 11551.57
|
32622.67 nanograms*hours/millilitres (ng*hr/mL)
Standard Deviation 11670.63
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1Population: The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration time data.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I
Cycle 1/Day 1 (n=11, 15, 10, 17)
|
3.98 hours
Interval 1.07 to 6.75
|
2.03 hours
Interval 1.0 to 7.0
|
2.92 hours
Interval 0.5 to 7.0
|
2.08 hours
Interval 1.0 to 4.08
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I
Cycle 1/Day 22 (n=9, 12, 9, 15)
|
1.98 hours
Interval 1.0 to 7.0
|
2.06 hours
Interval 0.95 to 4.25
|
2 hours
Interval 0.67 to 7.0
|
2 hours
Interval 0.0 to 7.05
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1Population: The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Maximum observed plasma concentration following drug administration was calculated from the raw plasma concentration time data.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 Participants
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I
Cycle 1/Day 22 (n=9, 12, 9, 15)
|
769.22 nanograms/millitres(ng/mL)
Standard Deviation 496.021
|
944.17 nanograms/millitres(ng/mL)
Standard Deviation 553.395
|
1122 nanograms/millitres(ng/mL)
Standard Deviation 736.862
|
1930 nanograms/millitres(ng/mL)
Standard Deviation 677.949
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I
Cycle 1/Day 1 (n=11, 15, 10, 17)
|
191.18 nanograms/millitres(ng/mL)
Standard Deviation 82.464
|
246.39 nanograms/millitres(ng/mL)
Standard Deviation 211.034
|
642.5 nanograms/millitres(ng/mL)
Standard Deviation 486.709
|
618.88 nanograms/millitres(ng/mL)
Standard Deviation 403.466
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)Population: 60 patients with known (Hedgehog) Hh pathway activation status were analyzed, 10 patients, including all 5 patients with an objective response (3 with pediatric) , were Hh-positive (+). No Hh-negative patient had an objective response.
ORR was determined in the participants with mutations on Hh gene (Hh positive) and the participants without mutations on Hh gene (Hh negative).
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=3 Participants
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Percentage of Pediatric Participants With Objective Response Rate (ORR) by Hedgehog (Hh) Signaling Pathway Status
|
66.7 % pediatric Hh + responders
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)Population: The analysis was performed in FAS population. Here "Number of participants analysed" signifies treatment responders for the specified reporting group.
Duration of overall response (complete response (CR) or partial response (PR)) was calculated for those participants whose best overall response was CR or PR. The start date was the date of the first documented tumor response (CR or PR) and the end date was the date of the event defined as the first documented progression or death due to underlying cancer or after the same treatment line. If a participant did not have a progression or death, the duration of response was censored at the date of last adequate tumor assessment in that treatment line.
Outcome measures
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
Pediatric Participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=1 Participants
Pediatric Participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=1 Participants
Pediatric Participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
Pediatric Participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
n=3 Participants
Adult Participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Duration of Response by Treatment
|
—
|
7 months
Interval 7.0 to 7.0
|
8.1 months
Interval 8.1 to 8.1
|
—
|
4.86 months
Interval 4.6 to 8.7
|
Adverse Events
Pediatric Participants, LDE225 233 mg/m^2
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Pediatric Participants, LDE225 372 mg/m^2
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Pediatric Participants, LDE225 425 mg/m^2
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Pediatric Participants, LDE225 680 mg/m^2
Serious events: 14 serious events
Other events: 21 other events
Deaths: 0 deaths
Adult Participants, LDE225 800 mg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 participants at risk
Pediatric participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 participants at risk
Pediatric participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 participants at risk
Pediatric participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 participants at risk
Pediatric participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
n=16 participants at risk
Adult participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Vision Blurred
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
4/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Chest Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
General Physical Health Deterioration
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Cystitis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Myoglobin Blood Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Amnesia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Aphasia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Coma
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dysaesthesia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
4/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Hydrocephalus
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Intracranial Pressure Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Neurological Decompensation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Vascular disorders
Venous Insufficiency
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
Other adverse events
| Measure |
Pediatric Participants, LDE225 233 mg/m^2
n=11 participants at risk
Pediatric participants received LDE225 233 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 372 mg/m^2
n=16 participants at risk
Pediatric participants received LDE225 372 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 425 mg/m^2
n=11 participants at risk
Pediatric participants received LDE225 425 mg/m\^2 once daily through oral route.
|
Pediatric Participants, LDE225 680 mg/m^2
n=22 participants at risk
Pediatric participants received LDE225 680 mg/m\^2 once daily through oral route.
|
Adult Participants, LDE225 800 mg
n=16 participants at risk
Adult participants were treated with LDE225 800 mg capsule once daily.
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Polyuria
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Cardiac disorders
Left Ventricular Hypertrophy
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Reproductive system and breast disorders
Penile Pain
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
4/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Ear Canal Stenosis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Blindness Unilateral
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Diplopia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Dry Eye
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Strabismus
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Eye disorders
Visual Impairment
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
22.7%
5/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Anal Pruritus
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
37.5%
6/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
4/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
31.2%
5/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
8/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Odynophagia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Oral Dysaesthesia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Tooth Disorder
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Toothache
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
5/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
56.2%
9/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
63.6%
7/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
68.2%
15/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Asthenia
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Chest Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Chills
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Face Oedema
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Facial Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Fatigue
|
45.5%
5/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
43.8%
7/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
6/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Gait Disturbance
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Performance Status Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Catheter Site Cellulitis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Conjunctivitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Skin Infection
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Injury, poisoning and procedural complications
Vascular Procedure Complication
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Alanine Aminotransferase Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
6/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
50.0%
8/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Fibrinogen Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Magnesium Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Blood Urea Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Lymphocyte Count Decreased
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
Weight Decreased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Investigations
White Blood Cell Count Decreased
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
4/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Epiphyseal Disorder
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
45.5%
5/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
25.0%
4/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
4/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
22.7%
5/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
31.2%
5/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
37.5%
6/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
4/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Posture Abnormal
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Sensation Of Heaviness
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular Joint Syndrome
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Ataxia
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
4/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Balance Disorder
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Brain Oedema
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Cerebellar Syndrome
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Coma
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Coordination Abnormal
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Facial Nerve Disorder
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Facial Paresis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Headache
|
54.5%
6/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
43.8%
7/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
36.4%
4/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
40.9%
9/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
13.6%
3/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
III rd Nerve Paresis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Intracranial Pressure Increased
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Lethargy
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Meningism
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Neurological Decompensation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
VII th Nerve Paralysis
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Nervous system disorders
VI th Nerve Disorder
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Confusional State
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Psychiatric disorders
Paranoia
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Micturition Disorder
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Micturition Urgency
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Renal and urinary disorders
Neurogenic Bladder
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
45.5%
5/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
27.3%
3/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Fungating Wound
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
18.8%
3/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
2/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Skin and subcutaneous tissue disorders
Solar Dermatitis
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Vascular disorders
Haematoma
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
12.5%
2/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
4.5%
1/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
6.2%
1/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
|
Vascular disorders
Pallor
|
0.00%
0/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
9.1%
1/11 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/22 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
0.00%
0/16 • Adverse Events are collected from First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), Week 73. All Adverse events are reported in this record from First Participant First Treatment until LPLV, Week 73.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 -778 -8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single--site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER