Trial Outcomes & Findings for Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma (NCT NCT02266147)
NCT ID: NCT02266147
Last Updated: 2020-09-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to Day 36
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
1 mg/mL
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
PART 1: Dose Escalation
STARTED
|
3
|
3
|
3
|
4
|
|
PART 1: Dose Escalation
COMPLETED
|
2
|
0
|
0
|
0
|
|
PART 1: Dose Escalation
NOT COMPLETED
|
1
|
3
|
3
|
4
|
|
PART 2: Dose Expansion
STARTED
|
7
|
0
|
0
|
9
|
|
PART 2: Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
|
PART 2: Dose Expansion
NOT COMPLETED
|
7
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
1 mg/mL
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
PART 1: Dose Escalation
Physician Decision
|
0
|
0
|
1
|
0
|
|
PART 1: Dose Escalation
Lack of Efficacy
|
0
|
2
|
1
|
1
|
|
PART 1: Dose Escalation
Study Terminated by Sponsor
|
0
|
0
|
1
|
3
|
|
PART 1: Dose Escalation
Other
|
1
|
1
|
0
|
0
|
|
PART 2: Dose Expansion
Lack of Efficacy
|
1
|
0
|
0
|
1
|
|
PART 2: Dose Expansion
Study Terminated by Sponsor
|
6
|
0
|
0
|
8
|
Baseline Characteristics
Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
1 mg/mL
n=10 Participants
PART 1
COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1
COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9.54 • n=7 Participants
|
61 years
STANDARD_DEVIATION 16.52 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 12.32 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 12.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety population
Outcome measures
| Measure |
1 mg/mL
n=10 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD).
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to Day 36Population: Safety population
Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain
Outcome measures
| Measure |
1 mg/mL
n=10 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Number of Participants Experiencing Injection-site Reactions (ISRs)
Injection site reaction 1
|
4 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Experiencing Injection-site Reactions (ISRs)
Injection site reaction 2
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Experiencing Injection-site Reactions (ISRs)
Injection site reaction 3
|
7 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 38 weeksPopulation: Safety population
Outcome measures
| Measure |
1 mg/mL
n=10 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
Renal and urinary disorders
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
Respiratory, thoracic and mediastinal disorders
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
Total # of participants with SAEs
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Change from Day 8 to Day 9Fold change of IFN-responsive gene expression relative to Day 8
Outcome measures
| Measure |
1 mg/mL
n=10 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB)
|
7.42 Fold Change
Standard Deviation 4.78
|
8.06 Fold Change
Standard Deviation 2.05
|
9.89 Fold Change
Standard Deviation .59
|
7.78 Fold Change
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: Up to 38 weeksPopulation: ITT population
Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Outcome measures
| Measure |
1 mg/mL
n=9 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Number of Participants With Preliminary Response - Local (Injected Lesions)
|
6 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 38 weeksPopulation: ITT population
Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Outcome measures
| Measure |
1 mg/mL
n=9 Participants
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 Participants
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 Participants
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 Participants
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Number of Participants With Preliminary Response - Systemic (Non-injected Lesions)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
1 mg/mL
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
2 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4 mg/mL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
8 mg/mL
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg/mL
n=10 participants at risk
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 participants at risk
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 participants at risk
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 participants at risk
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
Other adverse events
| Measure |
1 mg/mL
n=10 participants at risk
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
|
2 mg/mL
n=3 participants at risk
PART 1
COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
|
4 mg/mL
n=3 participants at risk
PART 1
COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
|
8 mg/mL
n=13 participants at risk
PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;
PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
|
|---|---|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
General disorders
Injection Site Erythema
|
40.0%
4/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
23.1%
3/13 • Up to 38 weeks
|
|
General disorders
Injection Site Swelling
|
30.0%
3/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Injection site discolouration
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
General disorders
Injection site pruritus
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Injection site rash
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
General disorders
Local swelling
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Malaise
|
90.0%
9/10 • Up to 38 weeks
|
66.7%
2/3 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
13/13 • Up to 38 weeks
|
|
General disorders
Oedema
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
General disorders
Pyrexia
|
40.0%
4/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
66.7%
2/3 • Up to 38 weeks
|
92.3%
12/13 • Up to 38 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Immune system disorders
Food allergy
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Infections and infestations
Herpes virus infection
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Up to 38 weeks
|
66.7%
2/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Infections and infestations
Viral infection
|
10.0%
1/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
23.1%
3/13 • Up to 38 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
10.0%
1/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
30.8%
4/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
61.5%
8/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Pancreatic cyst
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
38.5%
5/13 • Up to 38 weeks
|
|
General disorders
Asthenia
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Chills
|
80.0%
8/10 • Up to 38 weeks
|
66.7%
2/3 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
13/13 • Up to 38 weeks
|
|
General disorders
Exercise tolerance decreased
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Fatigue
|
80.0%
8/10 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
92.3%
12/13 • Up to 38 weeks
|
|
General disorders
Feeling hot
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Blood calcium decreased
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Blood chloride increased
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Dna antibody positive
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Eosinophil count decreased
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Investigations
Protein total decreased
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
70.0%
7/10 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
13/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Nervous system disorders
Headache
|
80.0%
8/10 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
100.0%
3/3 • Up to 38 weeks
|
84.6%
11/13 • Up to 38 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Nervous system disorders
Parosmia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
20.0%
2/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
30.0%
3/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
15.4%
2/13 • Up to 38 weeks
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • Up to 38 weeks
|
33.3%
1/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/13 • Up to 38 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
0.00%
0/3 • Up to 38 weeks
|
7.7%
1/13 • Up to 38 weeks
|
Additional Information
Robert Janssen MD \ VP & Chief Medical Officer
Dynavax Technologies, Inc.
Phone: 510-665-0414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60