Trial Outcomes & Findings for Patient-Centered Models of HCV Care for People Who Inject Drugs (NCT NCT02824640)

Results Overview

HCV viral load undetectable 12 weeks after treatment completion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

755 participants

Primary outcome timeframe

12 weeks after treatment completion

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Navigation The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support. Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group. Optional Weekly Support Groups: Subjects randomized to the PN arm will be offered weekly support groups led by Peers. Patient Navigation: The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.	Modified Directly Observed Therapy OAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack. Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant. modified Directly Observed Therapy: Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.
Overall Study STARTED	379	376
Overall Study COMPLETED	264	251
Overall Study NOT COMPLETED	115	125

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient-Centered Models of HCV Care for People Who Inject Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Navigation n=379 Participants The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support. Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group. Optional Weekly Support Groups: Subjects randomized to the PN arm will be offered weekly support groups led by Peers. Patient Navigation: The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.	Modified Directly Observed Therapy n=376 Participants OAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack. Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant. modified Directly Observed Therapy: Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.	Total n=755 Participants Total of all reporting groups
Age, Continuous	43.1 Years n=5 Participants	43.6 Years n=7 Participants	43.4 Years n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	109 Participants n=7 Participants	218 Participants n=5 Participants
Sex: Female, Male Male	270 Participants n=5 Participants	267 Participants n=7 Participants	537 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	250 race n=5 Participants	226 race n=7 Participants	476 race n=5 Participants
Race/Ethnicity, Customized Black/African American	37 race n=5 Participants	66 race n=7 Participants	103 race n=5 Participants
Race/Ethnicity, Customized Other	81 race n=5 Participants	70 race n=7 Participants	151 race n=5 Participants
Race/Ethnicity, Customized Missing	11 race n=5 Participants	14 race n=7 Participants	25 race n=5 Participants
Urine Drug Screen Results at Baseline Positive for Any drug	329 urine drug tests n=5 Participants	326 urine drug tests n=7 Participants	655 urine drug tests n=5 Participants
Urine Drug Screen Results at Baseline Negative for Any Drug	15 urine drug tests n=5 Participants	12 urine drug tests n=7 Participants	27 urine drug tests n=5 Participants
Urine Drug Screen Results at Baseline Missing	35 urine drug tests n=5 Participants	38 urine drug tests n=7 Participants	73 urine drug tests n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after treatment completion

Population: The total N=755 is the number of participants who was randomized between modified Directly Observed Therapy (mDOT) and Patient Navigation (PN) study arms. This sample is referred to as intention-to-treat (ITT) sample int he HERO study.

HCV viral load undetectable 12 weeks after treatment completion.

Outcome measures

Outcome measures
Measure	mDOT n=376 Participants mDOT was delivered at both settings and considered a modified version of DOT as not all doses were directly observed	Patient Navigation n=379 Participants The PN model was developed by the New York City Department of Health and Mental Hygiene. PNs had four roles: (1) coordinating HCV treatment, (2) health education and promotion, (3) assisting participants to overcome personal and structural barriers, and (4) providing psychosocial and adherence support.
Sustained Viral Response (SVR)	226 participants	236 participants

SECONDARY outcome

Timeframe: Up to 12 weeks after study enrollment

Population: ITT sample, that is, all of the participants who were randomized.

(Yes/No). Subject who receive at least one dose of HCV medication (sofosbuvir + velpatasvir) will be considered to have initiated HCV treatment. Those who do not receive one dose within 12 weeks of study enrollment will have been considered not to have initiated HCV treatment.

Outcome measures

Outcome measures
Measure	mDOT n=376 Participants mDOT was delivered at both settings and considered a modified version of DOT as not all doses were directly observed	Patient Navigation n=379 Participants The PN model was developed by the New York City Department of Health and Mental Hygiene. PNs had four roles: (1) coordinating HCV treatment, (2) health education and promotion, (3) assisting participants to overcome personal and structural barriers, and (4) providing psychosocial and adherence support.
HCV DAA Treatment Initiation	306 Number of patients who initiated treatme	317 Number of patients who initiated treatme

SECONDARY outcome

Timeframe: During 12 weeks of treatment

Population: mITtT

Electronic blister pack data were used to estimate daily adherence, calculated as a binary measure indicating whether one or more doses was taken per day. Weekly adherence levels were then computed in terms of percentages, that is, the number of adherent days out of 7 days for each participant.

Outcome measures

Outcome measures
Measure	mDOT n=306 Participants mDOT was delivered at both settings and considered a modified version of DOT as not all doses were directly observed	Patient Navigation n=317 Participants The PN model was developed by the New York City Department of Health and Mental Hygiene. PNs had four roles: (1) coordinating HCV treatment, (2) health education and promotion, (3) assisting participants to overcome personal and structural barriers, and (4) providing psychosocial and adherence support.
Adherence (by Electronic Monitors)	78 Percent Adherence Interval 74.8 to 81.4	73.4 Percent Adherence Interval 70.1 to 76.6

SECONDARY outcome

Timeframe: After 12 weeks of treatment

Population: The number of participants analyzed refer to the number of randomized participants, i.e., the intention-to-treat sample

(Yes/No) Treatment completion was declared if there were ≥84 days between the treatment initiation and completion.

Outcome measures

Outcome measures
Measure	mDOT n=376 Participants mDOT was delivered at both settings and considered a modified version of DOT as not all doses were directly observed	Patient Navigation n=379 Participants The PN model was developed by the New York City Department of Health and Mental Hygiene. PNs had four roles: (1) coordinating HCV treatment, (2) health education and promotion, (3) assisting participants to overcome personal and structural barriers, and (4) providing psychosocial and adherence support.
HCV DAA Treatment Completion	251 # of patients who completed treatment	264 # of patients who completed treatment

SECONDARY outcome

Timeframe: At weeks 12 or 24

NS5A resistance by Monogram assays.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At weeks 12 or 24

NS5B resistance by Monogram assays

Outcome measures

Outcome data not reported

Adverse Events

Modified Directly Observed Therapy

Serious events: 6 serious events

Other events: 3 other events

Deaths: 18 deaths

Patient Navigation

Serious events: 11 serious events

Other events: 2 other events

Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure	Modified Directly Observed Therapy n=376 participants at risk OAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack. Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant. modified Directly Observed Therapy: Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.	Patient Navigation n=379 participants at risk The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support. Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group.
Renal and urinary disorders Hospitalized for kidney stones	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.26% 1/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Injury, poisoning and procedural complications Laceration of right thigh	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Surgical and medical procedures Laryngectomy	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Injury, poisoning and procedural complications Non-fatal heroin overdose	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.53% 2/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Injury, poisoning and procedural complications Overdose	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.53% 2/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Skin and subcutaneous tissue disorders Staph Infection	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Psychiatric disorders Suicidal Ideation	0.53% 2/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	1.3% 5/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Injury, poisoning and procedural complications stab wound - lungs punctured	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.26% 1/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event

Other adverse events

Other adverse events
Measure	Modified Directly Observed Therapy n=376 participants at risk OAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack. Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant. modified Directly Observed Therapy: Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.	Patient Navigation n=379 participants at risk The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support. Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group.
Skin and subcutaneous tissue disorders Tinea cruris	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Skin and subcutaneous tissue disorders Itching, crawling skin	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Psychiatric disorders suicidality/psychiatric distress protocol used	0.27% 1/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.00% 0/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
Renal and urinary disorders Dysuria	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.26% 1/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event
General disorders Leg cramps, abdominal discomfort	0.00% 0/376 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event	0.26% 1/379 • The adverse event data were collected from baseline to the last visit week, which was 168 weeks after baseline. Therefore, the time frame for the adverse event data collections was 168 weeks, that is slightly longer than 3 years. An adverse event will be considered serious when the outcome is: * Death * Life-threatening * Hospitalization (initial or prolonged) * Disability or permanent damage * Congenital Anomaly/Birth Defect * Required intervention to prevent permanent impairment or damage (devices) * Other serious important medical event

Additional Information

Megan Groome

Prisma Health

Phone: 864-382-1023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place