Trial Outcomes & Findings for Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH). (NCT NCT03338998)
NCT ID: NCT03338998
Last Updated: 2022-08-12
Results Overview
Following the initial diagnostic CT, repeat CT images were obtained between 24-48 h after the diagnostic scan, and on Day 7 and Day 14 to capture the trajectory of PHE increase and plateau after ICH. Only non-contrast study CT scans were obtained on Day 7 and Day 14. The non-contrast scan acquired on each patient at first follow-up (i.e. 24-48 h after the diagnostic scan) served as the baseline for our analysis. All CT scans were uploaded through a secure server, and edema and hematoma volumes were measured in a semi-automated manner by one Central Reader.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
On Day 14 following ICH
Results posted on
2022-08-12
Participant Flow
Participant milestones
| Measure |
BAF312
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
|---|---|---|
|
Treatment Period
STARTED
|
16
|
13
|
|
Treatment Period
COMPLETED
|
8
|
10
|
|
Treatment Period
NOT COMPLETED
|
8
|
3
|
|
Safety Follow-Up Period
STARTED
|
16
|
13
|
|
Safety Follow-Up Period
COMPLETED
|
14
|
12
|
|
Safety Follow-Up Period
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
BAF312
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
|---|---|---|
|
Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Treatment Period
Adverse Event
|
0
|
2
|
|
Treatment Period
Protocol deviation
|
1
|
0
|
|
Treatment Period
Physician Decision
|
2
|
0
|
|
Treatment Period
Subject failed swallow test
|
4
|
0
|
|
Safety Follow-Up Period
Adverse Event
|
0
|
1
|
|
Safety Follow-Up Period
Protocol deviation
|
1
|
0
|
|
Safety Follow-Up Period
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
Baseline characteristics by cohort
| Measure |
BAF312
n=16 Participants
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
n=13 Participants
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.06 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Absolute perihematoma edema (aPHE) volume
|
32.927 mL
STANDARD_DEVIATION 32.3153 • n=5 Participants
|
22.825 mL
STANDARD_DEVIATION 9.8617 • n=7 Participants
|
28.237 mL
STANDARD_DEVIATION 24.7188 • n=5 Participants
|
PRIMARY outcome
Timeframe: On Day 14 following ICHPopulation: Per protocol analysis set
Following the initial diagnostic CT, repeat CT images were obtained between 24-48 h after the diagnostic scan, and on Day 7 and Day 14 to capture the trajectory of PHE increase and plateau after ICH. Only non-contrast study CT scans were obtained on Day 7 and Day 14. The non-contrast scan acquired on each patient at first follow-up (i.e. 24-48 h after the diagnostic scan) served as the baseline for our analysis. All CT scans were uploaded through a secure server, and edema and hematoma volumes were measured in a semi-automated manner by one Central Reader.
Outcome measures
| Measure |
BAF312
n=14 Participants
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
n=13 Participants
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
|---|---|---|
|
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)
|
55.09 mL
Interval 42.444 to 71.509
|
52.50 mL
Interval 40.042 to 68.835
|
SECONDARY outcome
Timeframe: Days 1, 8, and 14Population: Pharmacokinetics analysis set that included participants with at least one blood sample available
Blood samples will be collected to assess plasma concentrations.
Outcome measures
| Measure |
BAF312
n=11 Participants
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
|---|---|---|
|
Plasma BAF312 Concentrations
Day 1 - 0.1 Hours Post I.V. Dose n=11
|
0.1658 ng/mL
Geometric Coefficient of Variation 85.6
|
—
|
|
Plasma BAF312 Concentrations
Day 1 - 2 Hours Post I.V. Dose n=11
|
0.5663 ng/mL
Geometric Coefficient of Variation 78.7
|
—
|
|
Plasma BAF312 Concentrations
Day 1 - 6 Hours Post I.V. Dose n=10
|
2.4313 ng/mL
Geometric Coefficient of Variation 30.5
|
—
|
|
Plasma BAF312 Concentrations
Day 8 - 0 Hours Pre Oral Dose n=11
|
81.9423 ng/mL
Geometric Coefficient of Variation 55.9
|
—
|
|
Plasma BAF312 Concentrations
Day 14 - 0 Hours Pre Oral Dose n=11
|
36.4460 ng/mL
Geometric Coefficient of Variation 550.8
|
—
|
Adverse Events
BAF312
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Total
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAF312
n=16 participants at risk
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
n=13 participants at risk
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
Total
n=29 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Cardiac disorders
Cardiomyopathy
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Ischaemic stroke
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Renal and urinary disorders
Renal failure
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
Other adverse events
| Measure |
BAF312
n=16 participants at risk
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
|
Placebo
n=13 participants at risk
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
|
Total
n=29 participants at risk
Total
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Cardiac disorders
Bradycardia
|
31.2%
5/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
17.2%
5/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Cardiac disorders
Ventricular tachycardia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
13.8%
4/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Infusion site extravasation
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Infusion site irritation
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Injection site swelling
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Pain
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Peripheral swelling
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
General disorders
Swelling face
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Investigations
Blood bicarbonate decreased
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Investigations
Transaminases increased
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Aphasia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Facial paralysis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Nervous system disorders
Hydrocephalus
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Confusional state
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Hallucination, visual
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Restlessness
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Renal and urinary disorders
Azotaemia
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
15.4%
2/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
7.7%
1/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
0.00%
0/13 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment (14 days) plus 76 days post treatment, up to approximately of 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER