Trial Outcomes & Findings for A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus (NCT NCT01127321)
NCT ID: NCT01127321
Last Updated: 2014-08-26
Results Overview
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Day 1 to Day 169
Results posted on
2014-08-26
Participant Flow
Due to premature termination of the study, planned treatment cohorts, MEDI-570, 3 milligram (mg) and MEDI-570, 10 mg, were not administered. A total of 17 participants were randomized in the study. An additional 27 participants were screened but not randomized in the study.
Participant milestones
| Measure |
Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
1
|
7
|
5
|
|
Overall Study
COMPLETED
|
3
|
1
|
1
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
n=7 Participants
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
n=5 Participants
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION NA • n=7 Participants
|
41.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 22.2 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
38.4 years
STANDARD_DEVIATION 16.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 169Population: Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=3 Participants
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
n=7 Participants
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
n=5 Participants
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 participants
|
1 participants
|
1 participants
|
7 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169Population: Due to early termination of the study, the results were reported as individual participant's listings but not statistically summarized.
Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose on Day 1; Day 85, 113, and 169Population: Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.
Outcome measures
| Measure |
Placebo
n=3 Participants
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
n=1 Participants
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
n=7 Participants
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
n=5 Participants
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-570 0.03 MG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MEDI-570 0.1 MG
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
MEDI-570 0.3 MG
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
MEDI-570 1 MG
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
n=1 participants at risk
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
n=1 participants at risk
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
n=7 participants at risk
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
n=5 participants at risk
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
|
MEDI-570 0.03 MG
n=1 participants at risk
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
|
MEDI-570 0.1 MG
n=1 participants at risk
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
|
MEDI-570 0.3 MG
n=7 participants at risk
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
|
MEDI-570 1 MG
n=5 participants at risk
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Cardiac disorders
Pericarditis
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
40.0%
2/5 • Number of events 3 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
General disorders
Fatigue
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
28.6%
2/7 • Number of events 2 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
General disorders
General symptom
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
General disorders
Pain
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 2 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 2 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 2 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Investigations
Cd4 lymphocytes decreased
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
57.1%
4/7 • Number of events 4 • Day 1 to Day 169
|
80.0%
4/5 • Number of events 4 • Day 1 to Day 169
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
42.9%
3/7 • Number of events 3 • Day 1 to Day 169
|
40.0%
2/5 • Number of events 2 • Day 1 to Day 169
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/3 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
100.0%
1/1 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
33.3%
1/3 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
0.00%
0/5 • Day 1 to Day 169
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/7 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
0.00%
0/1 • Day 1 to Day 169
|
14.3%
1/7 • Number of events 1 • Day 1 to Day 169
|
20.0%
1/5 • Number of events 1 • Day 1 to Day 169
|
Additional Information
David Close, Director, Clinical Development
MedImmune, LLC.
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER