Trial Outcomes & Findings for A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT01602315)
NCT ID: NCT01602315
Last Updated: 2020-12-29
Results Overview
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR \> 1) \< 10%, and the posterior median HR \< 0.7.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
179 participants
Primary outcome timeframe
until disease progression or intolerable toxicity (approximately 6 months)
Results posted on
2020-12-29
Participant Flow
45 patients enrolled in Phase Ib, 106 cetuximab naïve patients in Phase II were randomized to either BYL719+cet (N=71) or cet monotherapy (N=35). Of the 35 patients, 16 crossed over to BYL719+cet combo treatment. 29 patients enrolled in the non-randomized combo treatment arm (cet resistant patients). All patients have completed the trial.
One patient was prematurely randomized at the site but was never treated.
Participant milestones
| Measure |
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
|
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 3 - BYL719+Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
5
|
18
|
6
|
71
|
35
|
29
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
5
|
18
|
6
|
71
|
35
|
29
|
Reasons for withdrawal
| Measure |
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
|
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 3 - BYL719+Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Overall Study
Disease progression
|
6
|
3
|
10
|
1
|
41
|
12
|
15
|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
7
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
6
|
0
|
1
|
|
Overall Study
Adverse Event
|
5
|
1
|
5
|
4
|
15
|
3
|
9
|
|
Overall Study
Subject/guardian decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Cross-over patients to combo treatment
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
Baseline Characteristics
A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
|
Arm A - 400mg BYL719+Cetuximab
n=5 Participants
400 mg BYL719 as FC whole tablets with cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=18 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=6 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
Arm 1 - BYL719+Cetuximab (Randomized)
n=71 Participants
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 2 - Monotherapy Cetuximab (Randomized)
n=35 Participants
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 3 - BYL719+Cetuximab (Non-randomized)
n=29 Participants
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 7.99 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 14.10 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 9.66 • n=21 Participants
|
57.1 years
STANDARD_DEVIATION 10.37 • n=8 Participants
|
56.9 years
STANDARD_DEVIATION 8.25 • n=8 Participants
|
57.0 years
STANDARD_DEVIATION 10.16 • n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
44 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
136 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: until disease progression or intolerable toxicity (approximately 6 months)Population: Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR \> 1) \< 10%, and the posterior median HR \< 0.7.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=11 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=3 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr(DLT) in 0-0.16
|
0.764 Probability of DLT rate
|
0.086 Probability of DLT rate
|
—
|
—
|
—
|
|
Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr (DLT) in 0.16-0.35
|
0.222 Probability of DLT rate
|
0.376 Probability of DLT rate
|
—
|
—
|
—
|
|
Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr (DLT) in 0.35-1
|
0.015 Probability of DLT rate
|
0.538 Probability of DLT rate
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: until disease progression or intolerable toxicity (approximately 6 months)Population: Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm B (crushed film-coated tablets as an oral suspension with swallowing dysfunction). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR \> 1) \< 10%, and the posterior median HR \< 0.7.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=13 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr(DLT) in 0-0.16
|
0.267 Probability of DLT rate
|
—
|
—
|
—
|
—
|
|
Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr (DLT) in 0.16-0.35
|
0.664 Probability of DLT rate
|
—
|
—
|
—
|
—
|
|
Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Posterior probabilities that Pr (DLT) in 0.35-1
|
0.069 Probability of DLT rate
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: until disease progression or intolerable toxicity (approximately 6 months)Population: Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction). 6 months is an approximate timeframe.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=11 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=3 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=13 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=3 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
n=30 Participants
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 Days)
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab. 6 months is an approximate timeframe.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=71 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Number of PFS events
|
46 participants
Interval 0.643 to 1.529
|
27 participants
|
—
|
—
|
—
|
|
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Progression
|
33 participants
|
25 participants
|
—
|
—
|
—
|
|
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Number of censored
|
25 participants
|
8 participants
|
—
|
—
|
—
|
|
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Death
|
13 participants
|
2 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab in patients resistant to platinum-based therapy and cetuximab.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=29 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II Arm 3: Progression Free Survival (PFS) as Per RECIST V1.1
|
3.896 months
Interval 2.868 to 5.241
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Comparison of single-dose exposure of BYL719 dispersible tablet via G-tube in combination with cetuximab in RM HNSCC to that of Arm A (film-coated tables)
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=6 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=5 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=17 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment
AUCinf
|
22600 hr*ng/mL
Interval 16600.0 to 48500.0
|
24100 hr*ng/mL
Interval 9290.0 to 33200.0
|
27800 hr*ng/mL
Interval 17200.0 to 60100.0
|
27300 hr*ng/mL
Interval 15700.0 to 47400.0
|
—
|
|
Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment
AUC0_24
|
18800 hr*ng/mL
Interval 5590.0 to 43400.0
|
19400 hr*ng/mL
Interval 7580.0 to 32100.0
|
26300 hr*ng/mL
Interval 16000.0 to 56100.0
|
25600 hr*ng/mL
Interval 14600.0 to 42100.0
|
—
|
|
Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment
AUClast
|
19200 hr*ng/mL
Interval 5830.0 to 42700.0
|
22100 hr*ng/mL
Interval 4390.0 to 31800.0
|
26200 hr*ng/mL
Interval 15800.0 to 55600.0
|
25000 hr*ng/mL
Interval 14400.0 to 41900.0
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full analysis Set (FAS) consisted of those patients who, after crossing over had received at least one dose of BYL719.
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Number of PFS
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Progression
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Death
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Number of Censored
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=5 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=18 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=6 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1
PFS event (Progression)
|
5 Participants
|
2 Participants
|
10 Participants
|
2 Participants
|
—
|
|
Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1
PFS event (Death)
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1
Number of Censored
|
9 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=71 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=106 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Complete Response
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Partial Response
|
6 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Stable Disease
|
24 Participants
|
8 Participants
|
32 Participants
|
—
|
—
|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Progressive Disease
|
17 Participants
|
12 Participants
|
29 Participants
|
—
|
—
|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Non-CR/Non-PD (NCRNPD)
|
6 Participants
|
10 Participants
|
16 Participants
|
—
|
—
|
|
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Unknown
|
17 Participants
|
3 Participants
|
20 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=29 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Complete Response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Partial Response (PR)
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Stable Disease (SD)
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Progressive Disease (PD)
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Non-CR/Non-PD (NCRNPD)
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Unknown
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arms 1 and 2.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=71 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=106 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Overall response rate (ORR) (CR or PR)
|
9.9 Percentages
Interval 4.1 to 19.3
|
5.7 Percentages
Interval 0.7 to 19.2
|
8.5 Percentages
Interval 4.0 to 15.5
|
—
|
—
|
|
Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Disease control rate 1 (DCR 1) (CR or PR or SD)
|
43.7 Percentages
Interval 31.9 to 56.0
|
28.6 Percentages
Interval 14.6 to 46.3
|
38.7 Percentages
Interval 29.4 to 48.6
|
—
|
—
|
|
Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
DCR 2 (CR or PR or SD or Non-CR/Non-PD)
|
52.1 Percentages
Interval 39.9 to 64.1
|
57.1 Percentages
Interval 39.4 to 73.7
|
53.8 Percentages
Interval 43.8 to 63.5
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Scheme 1 (arm 3): Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm 3 (non-randomized arm)
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=29 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Overall response rate (ORR) (CR or PR)
|
10.3 Percentages
Interval 2.2 to 27.4
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Disease control rate 1 (DCR 1) (CR or PR or SD)
|
37.9 Percentages
Interval 20.7 to 57.7
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
DCR 2 (CR or PR or SD or Non-CR/Non-PD)
|
58.6 Percentages
Interval 38.9 to 76.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 1 yearPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=71 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Randomized Overall Survival (OS) by Treatment
Number of censored
|
20 Patients
|
9 Patients
|
—
|
—
|
—
|
|
Phase II: Randomized Overall Survival (OS) by Treatment
Number of deaths
|
51 Patients
|
26 Patients
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 1 yearPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=29 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Non-Randomized Overall Survival (OS) by Treatment
Number of deaths
|
13 Patients
|
—
|
—
|
—
|
—
|
|
Phase II: Non-Randomized Overall Survival (OS) by Treatment
Number of censored
|
10 Patients
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C CR=complete response PR=partial response
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=5 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=18 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=6 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
n=45 Participants
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
ORR (CR) or PR)
|
25.5 Percentages
Interval 7.3 to 52.4
|
0.0 Percentages
Interval 0.0 to 52.2
|
0.0 Percentages
Interval 0.0 to 18.5
|
0.0 Percentages
Interval 0.0 to 45.9
|
8.9 Percentages
Interval 2.5 to 21.2
|
|
For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
DCR (CR or PR or Stable Disease or non-CR/Non-PD)
|
75.0 Percentages
Interval 47.6 to 92.7
|
20.0 Percentages
Interval 0.5 to 71.6
|
50.0 Percentages
Interval 26.0 to 74.0
|
16.7 Percentages
Interval 0.4 to 64.1
|
51.1 Percentages
Interval 35.8 to 66.3
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Phase II: Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab. Complete response (CR); Partial response (PR); Stable disease (SD)
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Overall Response (ORR) - CR or PR
|
0 Rate
none of the patients achieved complete response and partial response.
|
—
|
—
|
—
|
—
|
|
Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Disease Control Rate (DCR) - CR, PR, or SD
|
25.0 Rate
Interval 7.27 to 52.38
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 1 yearPopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=16 Participants
|
Arm A - 400mg BYL719+Cetuximab
|
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II, Scheme 2 (Arm 2B): Overall Survival (OS) for the Cross-over
|
96.0 Days
Interval 87.0 to 148.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 to 24 hours post dose (Day 1 Cycle 1)Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=5 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment
AUCinf
|
22600 hr*ng/mL
Interval 16600.0 to 48500.0
|
27300 hr*ng/mL
Interval 15700.0 to 47400.0
|
24100 hr*ng/mL
Interval 9290.0 to 33200.0
|
27800 hr*ng/mL
Interval 17200.0 to 60100.0
|
—
|
|
Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment
AUC0_24
|
18800 hr*ng/mL
Interval 5590.0 to 43400.0
|
25600 hr*ng/mL
Interval 14600.0 to 42100.0
|
19400 hr*ng/mL
Interval 7580.0 to 32100.0
|
26300 hr*ng/mL
Interval 16000.0 to 56100.0
|
—
|
|
Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment
AUClast
|
19200 hr*ng/mL
Interval 5830.0 to 42700.0
|
2370 hr*ng/mL
Interval 1330.0 to 3710.0
|
22100 hr*ng/mL
Interval 4390.0 to 31800.0
|
26200 hr*ng/mL
Interval 15800.0 to 55600.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 Cycle 1Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=5 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Cmax for BYL719 by Treatment
|
2130 ng/mL
Interval 303.0 to 4280.0
|
2370 ng/mL
Interval 1330.0 to 3710.0
|
2010 ng/mL
Interval 682.0 to 2980.0
|
2520 ng/mL
Interval 1800.0 to 6240.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 Cycle 1Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=5 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Tmax for BYL719 by Treatment
|
2.02 hr
Interval 1.0 to 24.8
|
2.97 hr
Interval 1.0 to 5.87
|
3 hr
Interval 0.767 to 6.0
|
2.23 hr
Interval 1.58 to 3.02
|
—
|
SECONDARY outcome
Timeframe: Day 1 Cycle 1Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)
AUClast
|
24500 hr*ng/mL
Interval 18000.0 to 76100.0
|
2370 hr*ng/mL
Interval 1330.0 to 3710.0
|
22100 hr*ng/mL
Interval 4390.0 to 31800.0
|
—
|
—
|
|
Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)
AUC (0-24)
|
24600 hr*ng/mL
Interval 17900.0 to 44400.0
|
28500 hr*ng/mL
Interval 12700.0 to 53900.0
|
30500 hr*ng/mL
Interval 30500.0 to 30500.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Cycle 1Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Cmax for BYL719 After Continuous Dose Administration (Steady State)
|
2200 ng/mL
Interval 1710.0 to 6520.0
|
2820 ng/mL
Interval 373.0 to 4710.0
|
2750 ng/mL
Interval 2750.0 to 2750.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Cycle 1Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=17 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=6 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Tmax for BYL719 After Continuous Dose Administration (Steady State)
|
3.15 hr
Interval 1.5 to 7.13
|
3.15 hr
Interval 1.03 to 8.0
|
1 hr
Interval 1.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=5 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=18 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=6 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): High only
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): Low only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): High only
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): Low only
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): High and low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): High only
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): Low only
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): High only
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): Low only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Weight (kg): High only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Weight (kg): Low only
|
7 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Weight (kg): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): High only
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): Low only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline, post baselinePopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=5 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=18 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
n=6 Participants
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcF (msec): Increase from baseline > 30
|
9 Participants
|
4 Participants
|
10 Participants
|
1 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcF (msec): Increase from baseline > 60
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcB (msec): Increase from baseline > 30
|
11 Participants
|
4 Participants
|
12 Participants
|
1 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcB (msec): Increase from baseline > 60
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QT (msec): Increase from baseline > 30
|
1 Participants
|
4 Participants
|
10 Participants
|
1 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QT (msec): Increase from baseline > 60
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
VR (bpm): RR decrease > 25% & to a VR > 100
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
VR (bpm): RR decrease > 25% & to a VR < 50
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
PR (msec): increase > 25% & to a VR > 200
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QRS (msec): increase > 25% & to a VR > 110
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=69 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=29 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): High only
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): Low only
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting Pulse rate (bpm): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): High only
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): Low only
|
11 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting systolic B.P. (mmHg): High and low
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): High only
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): Low only
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Sitting diastolic B.P. (mmHg): High and low
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): High only
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): Low only
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Body Temperature (Celsius): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Weight (kg): High only
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Weight (kg): Low only
|
31 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Weight (kg): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): High only
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): Low only
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
For Phase II: Notable Abnormal Vital Signs by Treatment
Respiratory Rate (bpm): High and low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, post baseline during the entire study period (approximately 1 year)Population: Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=69 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=29 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QRS (msec): increase > 25% & to a VR > 110
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcF (msec): Increase from baseline > 30
|
35 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcF (msec): Increase from baseline > 60
|
6 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcB (msec): Increase from baseline > 30
|
40 Participants
|
12 Participants
|
15 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QTcB (msec): Increase from baseline > 60
|
7 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QT (msec): Increase from baseline > 30
|
43 Participants
|
13 Participants
|
23 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
QT (msec): Increase from baseline > 60
|
17 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
VR (bpm): RR decrease > 25% & to a VR > 100
|
9 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
VR (bpm): RR decrease > 25% & to a VR < 50
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
PR (msec): increase > 25% & to a VR > 200
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 monthsPopulation: Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Outcome measures
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=71 Participants
|
Arm A - 400mg BYL719+Cetuximab
n=35 Participants
|
Arm B - BYL719 + Cetuximab, Oral Suspension
n=29 Participants
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
|
All Patients
All patients in Phase Ib
|
|---|---|---|---|---|---|
|
Phase II: Progression Free Survival (PFS) Based on Investigator's Assessment With Treatment
|
94.0 Days
Interval 58.0 to 135.0
|
85.0 Days
Interval 49.0 to 127.0
|
117.0 Days
Interval 50.0 to 184.0
|
—
|
—
|
Adverse Events
Arm A - 300mg BYL719+Cetuximab
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm A: 400 mg BYL719 + Cetuximab
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B - BYL719 + Cetuximab Oral Suspension
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm C - BYL719+Cetuximab Dispersible Tablets
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 1 - BYL719+Cetuximab (Randomized)
Serious events: 40 serious events
Other events: 69 other events
Deaths: 0 deaths
Arm 2 - Monotherapy Cetuximab (Randomized)
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Arm 3 - BYL719+Cetuximab (Non-randomized)
Serious events: 15 serious events
Other events: 29 other events
Deaths: 0 deaths
All Patients
Serious events: 99 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 participants at risk
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab
|
Arm A: 400 mg BYL719 + Cetuximab
n=5 participants at risk
400 mg BYL719 as FC whole tablets with cetuximab
|
Arm B - BYL719 + Cetuximab Oral Suspension
n=18 participants at risk
300mg BYL719 as crushed FC tablets with cetuximab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab Dispersible Tablets
n=6 participants at risk
300mg BYL719 dispersible tablets with cetuximab in patients with swallowing dysfunction administered via G-tube
|
Arm 1 - BYL719+Cetuximab (Randomized)
n=69 participants at risk
300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 2 - Monotherapy Cetuximab (Randomized)
n=35 participants at risk
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy
|
Arm 3 - BYL719+Cetuximab (Non-randomized)
n=29 participants at risk
300mg BYL719 with cetuximab in Phase II in patients resistant to Platinum-based therapy and cetuximab.
|
All Patients
n=178 participants at risk
All patients
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Chills
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.5%
8/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.6%
8/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.8%
4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.2%
20/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Superinfection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Pneumocephalus
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
7/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.2%
5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.4%
15/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Carotid artery perforation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Surgical and medical procedures
Gastrostomy
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
Other adverse events
| Measure |
Arm A - 300mg BYL719+Cetuximab
n=15 participants at risk
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab
|
Arm A: 400 mg BYL719 + Cetuximab
n=5 participants at risk
400 mg BYL719 as FC whole tablets with cetuximab
|
Arm B - BYL719 + Cetuximab Oral Suspension
n=18 participants at risk
300mg BYL719 as crushed FC tablets with cetuximab in patients with swallowing dysfunction
|
Arm C - BYL719+Cetuximab Dispersible Tablets
n=6 participants at risk
300mg BYL719 dispersible tablets with cetuximab in patients with swallowing dysfunction administered via G-tube
|
Arm 1 - BYL719+Cetuximab (Randomized)
n=69 participants at risk
300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
|
Arm 2 - Monotherapy Cetuximab (Randomized)
n=35 participants at risk
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy
|
Arm 3 - BYL719+Cetuximab (Non-randomized)
n=29 participants at risk
300mg BYL719 with cetuximab in Phase II in patients resistant to Platinum-based therapy and cetuximab.
|
All Patients
n=178 participants at risk
All patients
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.0%
9/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.1%
6/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.1%
7/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.0%
25/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Diplopia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Dry eye
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.5%
8/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Eye irritation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Eye pain
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Ocular hyperaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
50.0%
3/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.0%
9/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
7/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.2%
5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.9%
30/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.7%
7/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
55.6%
10/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
42.0%
29/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
44.8%
13/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
38.2%
68/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
7/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.3%
13/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
18.8%
13/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.2%
5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.0%
25/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.7%
6/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.1%
9/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
23.2%
16/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
37.9%
11/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.2%
43/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.1%
9/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Salivary gland mucocoele
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
46.7%
7/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
44.4%
8/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
44.9%
31/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.1%
6/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
41.4%
12/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
37.6%
67/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
3/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
21.7%
15/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.7%
6/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
18.0%
32/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Asthenia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Chills
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Cyst rupture
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Face oedema
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Facial pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.5%
8/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Fatigue
|
33.3%
5/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
27.8%
5/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
31.9%
22/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.9%
8/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
48.3%
14/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
31.5%
56/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
General physical health deterioration
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Malaise
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Mucosal dryness
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Oedema peripheral
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
27.8%
5/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.7%
6/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
12.4%
22/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Secretion discharge
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
General disorders
Submandibular mass
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Candida infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.7%
12/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Nail infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Paronychia
|
40.0%
6/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
27.8%
5/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
21.7%
15/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.1%
6/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
31.0%
9/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.2%
43/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Rash pustular
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Viral infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
7/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood glucose increased
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Blood testosterone decreased
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.1%
9/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Weight decreased
|
40.0%
6/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
6/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
50.0%
3/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
39.1%
27/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
7/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
37.9%
11/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
34.8%
62/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
6/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
37.7%
26/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
34.5%
10/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
29.8%
53/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
50.0%
3/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.3%
13/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
3/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.7%
12/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
53.3%
8/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
55.6%
10/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
83.3%
5/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
60.9%
42/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
55.2%
16/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
49.4%
88/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.4%
15/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
5/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
18.8%
13/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
27.6%
8/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
19.1%
34/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
53.3%
8/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
6/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
26.1%
18/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.9%
8/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
41.4%
12/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
30.9%
55/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
7/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.4%
15/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.2%
20/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.4%
15/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.7%
6/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.4%
15/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
50.0%
3/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.3%
13/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Aphasia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.2%
5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
9.0%
16/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Dysaesthesia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Dysgeusia
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.8%
4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
7/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.2%
20/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Hemiparesis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.5%
8/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.7%
6/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.3%
13/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Irritability
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
21.7%
15/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
7/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.7%
6/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.2%
36/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.8%
4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.7%
12/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
3/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
15.9%
11/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.3%
5/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
14.6%
26/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.9%
7/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.3%
13/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
6/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
46.7%
7/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
30.4%
21/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.9%
8/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.2%
5/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
26.4%
47/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.7%
4/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
2/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
26.1%
18/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.1%
6/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
34.5%
10/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.2%
43/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.8%
4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.5%
8/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
4.3%
3/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.8%
5/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
15.9%
11/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
18/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
46.7%
7/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
37.7%
26/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
40.0%
14/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.1%
7/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
33.7%
60/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
15.9%
11/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.7%
2/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.3%
3/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.8%
21/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
2/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
26.7%
4/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
17.4%
12/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.4%
4/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
24.1%
7/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.9%
30/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
10/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.9%
2/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
6.2%
11/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.2%
4/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Embolism
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.1%
2/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.56%
1/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
20.0%
1/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
7.2%
5/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
13.8%
4/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
10.1%
18/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.8%
4/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
8.6%
3/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
3.4%
1/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
5.1%
9/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
|
Vascular disorders
Lymphoedema
|
6.7%
1/15 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/5 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.4%
1/69 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
2.9%
1/35 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
0.00%
0/29 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
1.7%
3/178 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER