Trial Outcomes & Findings for Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study (NCT NCT02669433)

Last Updated: 2019-04-26

Results Overview

The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

484 participants

Primary outcome timeframe

Change from Baseline at 24 weeks

Results posted on

2019-04-26

Participant Flow

484 participants signed consent and were screened for participation. Of these, 306 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.

Participant milestones

Participant milestones
Measure	Placebo Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets
Overall Study STARTED	91	89	89
Overall Study Safety Population	91	89	88
Overall Study Intent to Treat (ITT) Population	89	89	87
Overall Study Per-Protocol Population	78	79	82
Overall Study Completers Population	73	72	69
Overall Study UPDRS Primary Population	87	87	84
Overall Study COMPLETED	76	75	74
Overall Study NOT COMPLETED	15	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets
Overall Study Protocol Violation	0	4	1
Overall Study Disease Progression	1	0	0
Overall Study Physician Decision	1	1	0
Overall Study Adverse Event	6	7	10
Overall Study Sponsor Termination	1	0	1
Overall Study Withdrawal by Subject	5	1	0
Overall Study Withdrawal by Caregiver	1	0	2
Overall Study Death	0	1	1

Baseline Characteristics

Data was missing for two subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=91 Participants Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=89 Participants Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=88 Participants Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets	Total n=268 Participants Total of all reporting groups
Age, Continuous	73.6 years n=91 Participants	73.0 years n=89 Participants	73.0 years n=88 Participants	73.0 years n=268 Participants
Age, Customized < 74 years	45 Participants n=91 Participants	45 Participants n=89 Participants	45 Participants n=88 Participants	135 Participants n=268 Participants
Age, Customized >/= 74 years	46 Participants n=91 Participants	44 Participants n=89 Participants	43 Participants n=88 Participants	133 Participants n=268 Participants
Age, Customized < 65 years	7 Participants n=91 Participants	9 Participants n=89 Participants	12 Participants n=88 Participants	28 Participants n=268 Participants
Age, Customized >/=65 years	84 Participants n=91 Participants	80 Participants n=89 Participants	76 Participants n=88 Participants	240 Participants n=268 Participants
Sex: Female, Male Female	20 Participants n=91 Participants	22 Participants n=89 Participants	15 Participants n=88 Participants	57 Participants n=268 Participants
Sex: Female, Male Male	71 Participants n=91 Participants	67 Participants n=89 Participants	73 Participants n=88 Participants	211 Participants n=268 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=91 Participants	6 Participants n=89 Participants	0 Participants n=88 Participants	10 Participants n=268 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=91 Participants	83 Participants n=89 Participants	86 Participants n=88 Participants	255 Participants n=268 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=91 Participants	0 Participants n=89 Participants	2 Participants n=88 Participants	3 Participants n=268 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=91 Participants	0 Participants n=89 Participants	0 Participants n=88 Participants	0 Participants n=268 Participants
Race (NIH/OMB) Asian	0 Participants n=91 Participants	3 Participants n=89 Participants	1 Participants n=88 Participants	4 Participants n=268 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=91 Participants	0 Participants n=89 Participants	0 Participants n=88 Participants	0 Participants n=268 Participants
Race (NIH/OMB) Black or African American	0 Participants n=91 Participants	4 Participants n=89 Participants	0 Participants n=88 Participants	4 Participants n=268 Participants
Race (NIH/OMB) White	90 Participants n=91 Participants	81 Participants n=89 Participants	85 Participants n=88 Participants	256 Participants n=268 Participants
Race (NIH/OMB) More than one race	0 Participants n=91 Participants	1 Participants n=89 Participants	0 Participants n=88 Participants	1 Participants n=268 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=91 Participants	0 Participants n=89 Participants	2 Participants n=88 Participants	3 Participants n=268 Participants
BMI	26.59 kg/m^2 n=90 Participants • Data was missing for two subjects	26.51 kg/m^2 n=89 Participants • Data was missing for two subjects	26.81 kg/m^2 n=87 Participants • Data was missing for two subjects	26.64 kg/m^2 n=266 Participants • Data was missing for two subjects

PRIMARY outcome

Timeframe: Change from Baseline at 24 weeks

Population: UPDRS Primary Population

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=72 Participants Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=69 Participants Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	-0.55 units on a scale Standard Error 1.039	1.45 units on a scale Standard Error 1.025	-1.29 units on a scale Standard Error 1.056

SECONDARY outcome

Timeframe: Change from Baseline at 24 weeks

Population: ITT Population

The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=73 Participants Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=71 Participants Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	1.68 units on a scale Standard Error 0.774	2.15 units on a scale Standard Error 0.769	1.01 units on a scale Standard Error 0.796

SECONDARY outcome

Timeframe: Change from Baseline at 24 weeks

Population: ITT Population

To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Subjects dosed with two Placebo tablets Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=74 Participants Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101 RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=72 Participants Subjects dosed with two RVT-101 35 mg tablets RVT-101 70 mg: once daily, oral, 35-mg tablets
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	4.42 units on a scale Standard Error 0.127	4.27 units on a scale Standard Error 0.128	4.35 units on a scale Standard Error 0.131

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 66 other events

Deaths: 1 deaths

RVT-101 35 mg

Serious events: 11 serious events

Other events: 69 other events

Deaths: 1 deaths

RVT-101 70 mg

Serious events: 13 serious events

Other events: 59 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=91 participants at risk Placebo Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=89 participants at risk RVT-101 35 mg once daily RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=88 participants at risk RVT-101 70 mg once daily RVT-101 70 mg: once daily, oral, 35-mg tablets
Injury, poisoning and procedural complications Fall	20.9% 19/91 • Screening through post treatment (up to 33 weeks)	19.1% 17/89 • Screening through post treatment (up to 33 weeks)	20.5% 18/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Urinary tract infection	4.4% 4/91 • Screening through post treatment (up to 33 weeks)	7.9% 7/89 • Screening through post treatment (up to 33 weeks)	8.0% 7/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Constipation	5.5% 5/91 • Screening through post treatment (up to 33 weeks)	10.1% 9/89 • Screening through post treatment (up to 33 weeks)	6.8% 6/88 • Screening through post treatment (up to 33 weeks)
Vascular disorders Orthostatic hypotension	13.2% 12/91 • Screening through post treatment (up to 33 weeks)	3.4% 3/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Respiratory, thoracic and mediastinal disorders Nasopharygitis	7.7% 7/91 • Screening through post treatment (up to 33 weeks)	9.0% 8/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Diarrhoea	3.3% 3/91 • Screening through post treatment (up to 33 weeks)	7.9% 7/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Hallucination, visual	4.4% 4/91 • Screening through post treatment (up to 33 weeks)	6.7% 6/89 • Screening through post treatment (up to 33 weeks)	3.4% 3/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Confusional state	3.3% 3/91 • Screening through post treatment (up to 33 weeks)	5.6% 5/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	7.9% 7/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Dizziness	4.4% 4/91 • Screening through post treatment (up to 33 weeks)	3.4% 3/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Nausea	2.2% 2/91 • Screening through post treatment (up to 33 weeks)	4.5% 4/89 • Screening through post treatment (up to 33 weeks)	5.7% 5/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Upper respiratory tract infection	6.6% 6/91 • Screening through post treatment (up to 33 weeks)	3.4% 3/89 • Screening through post treatment (up to 33 weeks)	2.3% 2/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Anxiety	3.3% 3/91 • Screening through post treatment (up to 33 weeks)	5.6% 5/89 • Screening through post treatment (up to 33 weeks)	2.3% 2/88 • Screening through post treatment (up to 33 weeks)
Vascular disorders Hypertension	5.5% 5/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	2.3% 2/88 • Screening through post treatment (up to 33 weeks)

Additional Information

Ilise Lombardo, MD

Axovant Sciences, Inc.

Phone: 646-822-8626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All proposed manuscripts, publications or abstracts must be reviewed and approved by the Sponsor 60 days prior to submission for publication. All confidential information identified by the Sponsor must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=91 participants at risk Placebo Placebo: once daily, oral, matching tablets	RVT-101 35 mg n=89 participants at risk RVT-101 35 mg once daily RVT-101 35 mg: once daily, oral, 35-mg tablets	RVT-101 70 mg n=88 participants at risk RVT-101 70 mg once daily RVT-101 70 mg: once daily, oral, 35-mg tablets
Vascular disorders Deep vein Thrombosis	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Concussion	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Spinal compression fracture	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Cardiac disorders Atrial Flutter	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Cardiac disorders Trifascicular block	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.2% 2/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Ischaemic stroke	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Dementia	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Encephalopathy	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Haemorrhagic stroke	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Metabolic encephalopathy	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Nervous system disorders Transient ischaemic attack	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Delirium	2.2% 2/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Depression	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Hallucination, visual	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Mental status change	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Psychiatric disorders Neuropsychiatric syndrome	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Enteritis	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Gastrointestinal disorders Volvulus	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Hepatobiliary disorders Cholecystitiis acute	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Renal and urinary disorders Nephrolithiasis	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Metabolism and nutrition disorders Dehydration	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Urinary tract infection	2.2% 2/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Pneumonia	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	2.3% 2/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Sepsis	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Escherichia urinary tract infection	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Lower respiratory tract infection	1.1% 1/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Pyelonephritis	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	0.00% 0/89 • Screening through post treatment (up to 33 weeks)	1.1% 1/88 • Screening through post treatment (up to 33 weeks)
Infections and infestations Urosepsis	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/91 • Screening through post treatment (up to 33 weeks)	1.1% 1/89 • Screening through post treatment (up to 33 weeks)	0.00% 0/88 • Screening through post treatment (up to 33 weeks)