Trial Outcomes & Findings for Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection (NCT NCT00850395)
NCT ID: NCT00850395
Last Updated: 2012-11-07
Results Overview
COMPLETED
79 participants
Baseline, Month 3
2012-11-07
Participant Flow
Participant milestones
| Measure |
Maraviroc
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Maraviroc
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Insufficient clinical response
|
3
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
Baseline characteristics by cohort
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Age Continuous
|
44.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA)
|
3.01 copies/milliliter (copies/mL)
STANDARD_DEVIATION 1.599 • n=5 Participants
|
|
Cluster of Differentiation 4 (CD4+) Cell Counts
|
458.8 cells/microliter (cells/mcL)
STANDARD_DEVIATION 250.14 • n=5 Participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification
Category A
|
31 participants
n=5 Participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification
Category B
|
21 participants
n=5 Participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification
Category C
|
27 participants
n=5 Participants
|
|
Acquired Immune Deficiency Syndrome Clinical Trials Group Symptom Distress Module(SDM) Overall Score
|
17.37 units on a scale
STANDARD_DEVIATION 14.026 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Maraviroc
n=75 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
|
-1.10 copies/mL
Standard Deviation 1.530
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Maraviroc
n=74 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
|
-1.15 copies/mL
Standard Deviation 1.579
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
|
-0.95 copies/mL
Standard Deviation 1.571
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Maraviroc
n=75 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
|
74.31 cells/mcL
Standard Deviation 162.18
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
Maraviroc
n=75 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
|
91.88 cells/mcL
Standard Deviation 168.43
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
|
97.57 cells/mcL
Standard Deviation 237.70
|
PRIMARY outcome
Timeframe: Month 3Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Outcome measures
| Measure |
Maraviroc
n=76 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Category A
|
31 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Category B
|
19 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
Category C
|
26 participants
|
PRIMARY outcome
Timeframe: Month 6Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Outcome measures
| Measure |
Maraviroc
n=74 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Category B
|
16 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Category A
|
31 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
Category C
|
27 participants
|
PRIMARY outcome
Timeframe: Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Category A
|
31 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Category B
|
20 participants
|
|
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
Category C
|
28 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12Population: FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.
SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Change at Month 6 (n=51)
|
-4.87 units on a scale
Standard Deviation 12.527
|
|
Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12
Change at Month 12 (n=79)
|
-2.14 units on a scale
Standard Deviation 11.728
|
SECONDARY outcome
Timeframe: Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
Response was defined as a HIV-1 RNA count of less than 50 copies/mL.
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Number of Participants With Human Immunodeficiency Virus (HIV) Response
|
51 participants
|
SECONDARY outcome
Timeframe: Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Physician's Assessment of Efficacy
Excellent
|
15 participants
|
|
Physician's Assessment of Efficacy
Very Good
|
42 participants
|
|
Physician's Assessment of Efficacy
Good
|
14 participants
|
|
Physician's Assessment of Efficacy
Fair
|
1 participants
|
|
Physician's Assessment of Efficacy
Poor
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS population included all participants who received at least one dose (including partial doses) of study medication.
Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).
Outcome measures
| Measure |
Maraviroc
n=79 Participants
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Number of Participants Taking Concomitant Therapy
ATV, FTC/TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RAL (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra, SQV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, DRV, RAL (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, RAL (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, FTC/TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, RAL (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, RAL, TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, RAL, TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC, FTC/TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC, FTC/TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
ABC/LAM, DRV, RAL (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, FTC/TDF, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, FTC/TDF, RTV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, LAM, RAL, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, LAM, RAL, RTV (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RAL (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RAL, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RAL, RTV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ATV, RTV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF, ETR (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF, ETR (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF, RTV (Month 12)
|
6 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, FTC/TDF, RTV (Baseline, Month 12)
|
5 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, ETV, ETR, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, ETV, ETR, RTV (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, RAL (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, RAL (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, RAL, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, RAL, RTV (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, LAM, TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, NVP, RAL, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, NVP, RAL, RTV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RAL, RTV (Month 12)
|
4 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RAL, RTV (Baseline, Month 12)
|
4 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RTV (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RTV (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RTV, TZV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
DRV, RTV, TZV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF (Month 12)
|
13 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF (Baseline, Month 12)
|
11 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra, RAL (Month 12)
|
3 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra, RAL (Baseline, Month 12)
|
3 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, Kaletra, SQV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, RAL (Month 12)
|
5 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, RAL (Baseline, Month 12)
|
4 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, RAL, SQV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
FTC/TDF, RAL, SQV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ETR, RAL, RTV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
ETR, RAL, RTV (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
Kaletra (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
Kaletra (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
LAM, RAL, TDF, ZDV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
LAM, RAL, TDF, ZDV (Baseline, Month 12)
|
0 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL (Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL (Baseline, Month 12)
|
2 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL, TDF (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL, TDF (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL, ZDV W/LAM (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
RAL, ZDV W/LAM (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
TDF, TZV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
TDF, TZV (Baseline, Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
TDF, ZDV (Month 12)
|
1 participants
|
|
Number of Participants Taking Concomitant Therapy
TDF, ZDV (Baseline, Month 12)
|
1 participants
|
Adverse Events
Maraviroc
Serious adverse events
| Measure |
Maraviroc
n=79 participants at risk
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Congenital, familial and genetic disorders
Ichthyosis
|
1.3%
1/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.3%
1/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
1/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.3%
1/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Maraviroc
n=79 participants at risk
Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
|
|---|---|
|
Infections and infestations
Bronchitis
|
5.1%
4/79
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER