Trial Outcomes & Findings for A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus. (NCT NCT01031836)
NCT ID: NCT01031836
Last Updated: 2018-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Stage I (up to 1 year)
Results posted on
2018-11-19
Participant Flow
This study was conducted at 7 centres in Japan. The first patient was enrolled on 25 November 2009 and the last enrolled patient had completed Stage II on 11 July 2016.
Thirty (30) patients received MEDI-545 either IV or SC treatment (5 patients in each cohort) at Stage I. Twenty-six (26) patients completed Stage I treatment and, out of these 26 patients, 21 patients were registered to continue in Stage II.
Participant milestones
| Measure |
MEDI-545 1.0 mg/kg IV
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEDI-545 3.0 mg/kg IV
MEDI-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100 mg SC
MEDI-545 100 mg SC once every 2 weeks
|
MEDI-545 600 mg IV
MEDI-545 600 mg IV once every 4 weeks
|
MEDI-545 1200 mg IV
MEDI-545 1200 mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Stage I
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Stage I
COMPLETED
|
4
|
3
|
5
|
5
|
5
|
4
|
|
Stage I
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
1
|
|
Stage II
STARTED
|
3
|
1
|
4
|
4
|
5
|
4
|
|
Stage II
COMPLETED
|
1
|
1
|
2
|
1
|
3
|
3
|
|
Stage II
NOT COMPLETED
|
2
|
0
|
2
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
MEDI-545 1.0 mg/kg IV
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEDI-545 3.0 mg/kg IV
MEDI-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100 mg SC
MEDI-545 100 mg SC once every 2 weeks
|
MEDI-545 600 mg IV
MEDI-545 600 mg IV once every 4 weeks
|
MEDI-545 1200 mg IV
MEDI-545 1200 mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Stage I
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Stage I
Other
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Stage II
Adverse Event
|
0
|
0
|
2
|
2
|
1
|
1
|
|
Stage II
Other
|
2
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Baseline characteristics by cohort
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEDI-545 3.0 mg/kg IV
n=5 Participants
MEDI-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100 mg SC
n=5 Participants
MEDI-545 100 mg SC once every 2 weeks
|
MEDI-545 600 mg IV
n=5 Participants
MEDI-545 600 mg IV once every 4 weeks
|
MEDI-545 1200 mg IV
n=5 Participants
MEDI-545 1200 mg IV once every 4 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 3 • n=5 Participants
|
43 years
STANDARD_DEVIATION 13 • n=7 Participants
|
34 years
STANDARD_DEVIATION 9 • n=5 Participants
|
37 years
STANDARD_DEVIATION 9 • n=4 Participants
|
46 years
STANDARD_DEVIATION 10 • n=21 Participants
|
48 years
STANDARD_DEVIATION 13 • n=8 Participants
|
40 years
STANDARD_DEVIATION 11 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Stage I (up to 1 year)Population: Safety population
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=5 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=5 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=5 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any AE
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any AE of CTC grade at least 3
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any AE with outcome=death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any serious adverse events (SAE)
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any AE leading to discontinuation of IP
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Category of Adverse Events in Stage I
Any causally related AE
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Stage II (1 year to 3.5 years after first dose)Population: Safety population
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=3 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=1 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=4 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=4 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=4 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any AE
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any AE of CTC grade at least 3
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any AE with outcome=death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any serious adverse events (SAE)
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any AE leading to discontinuation of IP
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Any causally related AE
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: After first dose in Stage I (0 upto 28 days)Population: Pharmacokinetics (PK) populaton
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=4 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=2 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=3 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=1 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=1 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=3 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
|
261.98 day*ug/mL
Full Range 16.8 • Interval 226.18 to 332.8
|
647.93 day*ug/mL
Full Range 7.4 • Interval 614.06 to 681.8
|
3040.83 day*ug/mL
Full Range 24.2 • Interval 2284.94 to 3670.57
|
239.16 day*ug/mL
Interval 239.16 to 239.16
|
2308.44 day*ug/mL
Interval 2308.44 to 2308.44
|
5235.41 day*ug/mL
Full Range 11.6 • Interval 4646.86 to 5857.94
|
SECONDARY outcome
Timeframe: After first dose in Stage IPopulation: PK populaton
Summary of area under the concentration-time curve from zero to Day 14.
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=5 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=5 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=5 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
AUC0-14 of MEDI-545 After First Dose in Stage I
|
151.28 day*ug/mL
Geometric Coefficient of Variation 19.3
|
432.26 day*ug/mL
Geometric Coefficient of Variation 11.0
|
1728.01 day*ug/mL
Geometric Coefficient of Variation 16.8
|
128.06 day*ug/mL
Geometric Coefficient of Variation 56.1
|
1965.44 day*ug/mL
Geometric Coefficient of Variation 41.4
|
4583.55 day*ug/mL
Geometric Coefficient of Variation 15.2
|
SECONDARY outcome
Timeframe: After first dose in Stage IPopulation: PK populaton
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=5 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=5 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=5 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
|
29.04 ug/mL
Geometric Coefficient of Variation 31.3
|
71.72 ug/mL
Geometric Coefficient of Variation 19.6
|
311.17 ug/mL
Geometric Coefficient of Variation 19.0
|
11.70 ug/mL
Geometric Coefficient of Variation 61.1
|
244.54 ug/mL
Geometric Coefficient of Variation 47.4
|
607.64 ug/mL
Geometric Coefficient of Variation 16.1
|
SECONDARY outcome
Timeframe: Stage IPopulation: Safety population
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=5 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=5 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=5 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 21-gene Signature Fold Change in Stage I
Day 3
|
-2.57 fold change
Standard Deviation 2.61
|
-4.53 fold change
Standard Deviation 7.02
|
-2.49 fold change
Standard Deviation 1.06
|
-1.80 fold change
Standard Deviation 0.97
|
-4.81 fold change
Standard Deviation 2.63
|
-3.37 fold change
Standard Deviation 1.69
|
|
Change From Baseline in 21-gene Signature Fold Change in Stage I
Day 15
|
-1.40 fold change
Standard Deviation 2.56
|
-1.11 fold change
Standard Deviation 5.99
|
-0.41 fold change
Standard Deviation 1.60
|
-0.59 fold change
Standard Deviation 1.69
|
-1.61 fold change
Standard Deviation 1.23
|
-1.84 fold change
Standard Deviation 1.72
|
|
Change From Baseline in 21-gene Signature Fold Change in Stage I
Day 29
|
0.03 fold change
Standard Deviation 2.54
|
-0.16 fold change
Standard Deviation 8.44
|
-0.34 fold change
Standard Deviation 1.38
|
-0.85 fold change
Standard Deviation 0.81
|
-1.13 fold change
Standard Deviation 1.40
|
-1.27 fold change
Standard Deviation 2.46
|
|
Change From Baseline in 21-gene Signature Fold Change in Stage I
Day 1 8 hours post-dose
|
-3.70 fold change
Standard Deviation 2.07
|
-5.68 fold change
Standard Deviation 5.92
|
-2.30 fold change
Standard Deviation 0.93
|
-1.17 fold change
Standard Deviation 0.80
|
-4.91 fold change
Standard Deviation 2.26
|
-3.44 fold change
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Stage IPopulation: Safety population
Outcome measures
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 Participants
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEID-545 3.0 mg/kg IV
n=5 Participants
MEID-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 Participants
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100mg SC
n=5 Participants
MEDI-545 100mg SC once every 2 weeks
|
MEDI-545 600mg IV
n=5 Participants
MEDI-545 600mg IV once every 4 weeks
|
MEDI-545 1200mg IV
n=5 Participants
MEDI-545 1200mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
MEDI-545 1.0 mg/kg IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-545 3.0 mg/kg IV
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI-545 10.0 mg/kg IV
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-545 100 mg SC
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-545 600 mg IV
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-545 1200 mg IV
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 participants at risk
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEDI-545 3.0 mg/kg IV
n=5 participants at risk
MEDI-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 participants at risk
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100 mg SC
n=5 participants at risk
MEDI-545 100 mg SC once every 2 weeks
|
MEDI-545 600 mg IV
n=5 participants at risk
MEDI-545 600 mg IV once every 4 weeks
|
MEDI-545 1200 mg IV
n=5 participants at risk
MEDI-545 1200 mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Ear and labyrinth disorders
Auditory disorders
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Hepatobiliary disorders
Budd-Chiari syndrome
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Nervous system disorders
Cerebral infaraction
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
Other adverse events
| Measure |
MEDI-545 1.0 mg/kg IV
n=5 participants at risk
MEDI-545 1.0 mg/kg IV once every 2 weeks
|
MEDI-545 3.0 mg/kg IV
n=5 participants at risk
MEDI-545 3.0 mg/kg IV once every 2 weeks
|
MEDI-545 10.0 mg/kg IV
n=5 participants at risk
MEDI-545 10.0 mg/kg IV once every 2 weeks
|
MEDI-545 100 mg SC
n=5 participants at risk
MEDI-545 100 mg SC once every 2 weeks
|
MEDI-545 600 mg IV
n=5 participants at risk
MEDI-545 600 mg IV once every 4 weeks
|
MEDI-545 1200 mg IV
n=5 participants at risk
MEDI-545 1200 mg IV once every 4 weeks
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
100.0%
3/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
100.0%
1/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
75.0%
3/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
80.0%
4/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
75.0%
3/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Otitis media
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Dental caries
|
40.0%
2/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
General disorders
Fatigue
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
40.0%
2/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
40.0%
2/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
100.0%
1/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
100.0%
1/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
20.0%
1/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
50.0%
2/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
33.3%
1/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
100.0%
1/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
40.0%
2/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/1 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
0.00%
0/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
40.0%
2/5 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
25.0%
1/4 • Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place