Trial Outcomes & Findings for Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) (NCT NCT03036813)

NCT ID: NCT03036813

Last Updated: 2023-07-27

Results Overview

Number of participants with increase in Hb \>1 g/dL from Baseline to Week 24

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

449 participants

Primary outcome timeframe

Baseline to Week 24

Results posted on

2023-07-27

Participant Flow

Overall, 449 subjects were screened for this study at 60 study sites. Between January 2017 and May 2018, a total of 274 subjects were randomized at 58 study sites across 12 countries. All 274 randomized subjects were included in the ITT Population. A total of 271 subjects received study drug and were included in the Safety Population.

Screening procedures were done within 35 days of randomization to assess eligibility.

Participant milestones

Participant milestones
Measure	Voxelotor 900mg Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks.	Voxelotor 1500mg Participants received voxelotor 1500 mg administered orally, once daily for 72 weeks.	Placebo Matching placebo; administered orally, once daily for 72 weeks.
Overall Study STARTED	92	90	92
Overall Study COMPLETED	70	63	66
Overall Study NOT COMPLETED	22	27	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Voxelotor 900mg Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks.	Voxelotor 1500mg Participants received voxelotor 1500 mg administered orally, once daily for 72 weeks.	Placebo Matching placebo; administered orally, once daily for 72 weeks.
Overall Study Adverse Event	6	11	6
Overall Study Withdrawal by Subject	12	6	10
Overall Study Lost to Follow-up	1	1	0
Overall Study Physician Decision	2	1	1
Overall Study Non-Compliance	1	5	3
Overall Study Pregnancy	0	0	1
Overall Study Other	0	3	5

Baseline Characteristics

Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voxelotor 900mg n=92 Participants Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks.	Voxelotor 1500mg n=90 Participants Participants received voxelotor 1500 mg; administered orally, once daily for 72 weeks	Placebo n=92 Participants Matching Placebo; administered orally, once daily for 72 weeks	Total n=274 Participants Total of all reporting groups
Age, Customized 12 to < 18	15 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	46 Participants n=4 Participants
Age, Customized >=18 to < 65	77 Participants n=5 Participants	76 Participants n=7 Participants	75 Participants n=5 Participants	228 Participants n=4 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	58 Participants n=7 Participants	50 Participants n=5 Participants	159 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	32 Participants n=7 Participants	42 Participants n=5 Participants	115 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	82 Participants n=7 Participants	85 Participants n=5 Participants	253 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Race · Arab/Middle Eastern	19 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	60 Participants n=5 Participants	59 Participants n=7 Participants	63 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	6 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Race · Multiple	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · Missing/ Not Specified	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Europe	19 participants n=5 Participants	19 participants n=7 Participants	18 participants n=5 Participants	56 participants n=4 Participants
Region of Enrollment North America	36 participants n=5 Participants	34 participants n=7 Participants	35 participants n=5 Participants	105 participants n=4 Participants
Region of Enrollment Egypt	15 participants n=5 Participants	16 participants n=7 Participants	13 participants n=5 Participants	44 participants n=4 Participants
Region of Enrollment Kenya	17 participants n=5 Participants	14 participants n=7 Participants	18 participants n=5 Participants	49 participants n=4 Participants
Region of Enrollment Jamaica	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Oman	2 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Lebanon	3 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All randomized subject (ITT population).

Number of participants with increase in Hb \>1 g/dL from Baseline to Week 24

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=92 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=90 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=92 Participants Participants received matching placebo; administered orally, once daily
Number of Participants With Increase in Hb >1 g/dL From Baseline to Week 24	30 Participants	46 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to Week 72

Population: Population excludes 3 subjects (1 in the placebo group and 2 in the voxelotor 1500-mg group) who were not treated.

Number of Vaso-Occlusive Crisis (VOC) events averaged per year.

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=92 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=88 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=91 Participants Participants received matching placebo; administered orally, once daily
Annualized Vaso-Occlusive Crisis (VOC) Incidence Rate	2.4 Events per year Interval 1.9 to 3.1	2.4 Events per year Interval 1.8 to 3.1	2.8 Events per year Interval 2.2 to 3.6

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Analysis population includes all randomized patients with a baseline value and at least one post-baseline value

Percentage change from Baseline to week 24 in unconjugated bilirubin

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=88 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=85 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=85 Participants Participants received matching placebo; administered orally, once daily
Percentage Change From Baseline in Hemolysis Measures	-20.1 percentage change Standard Error 3.41	-29.1 percentage change Standard Error 3.46	-2.8 percentage change Standard Error 3.51

SECONDARY outcome

Timeframe: Baseline to Week 24

Percentage change from Baseline to week 24 in the absolute reticulocyte which is used to estimate the degree of effective erythropoiesis. This values is important in Sickle Cell Disease and was reported by the central laboratory.

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=92 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=88 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=91 Participants Participants received matching placebo; administered orally, once daily
Percentage Change From Baseline in Hemolysis Measures	4.7 percentage change Standard Error 5.13	-6.4 percentage change Standard Error 5.17	4.7 percentage change Standard Error 5.19

SECONDARY outcome

Timeframe: Baseline to Week 24

Percentage change from Baseline to week 24 in reticulocytes % which is a % of total Red Blood Cells (RBCs).

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=92 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=88 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=91 Participants Participants received matching placebo; administered orally, once daily
Percentage Change From Baseline in Hemolysis Measures	-1.4 Percentage Change Standard Error 4.65	-18.0 Percentage Change Standard Error 4.70	6.8 Percentage Change Standard Error 4.73

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: Analysis population includes all randomized patients with a baseline value and at least one post-baseline value

Percentage change from Baseline to week 24 in Lactate Dehydrogenase (LDH)

Outcome measures

Outcome measures
Measure	Voxelotor 900 mg n=90 Participants Participants received voxelotor 900 mg administered orally, once daily	Voxelotor 1500 mg n=88 Participants Participants received voxelotor 1500mg; administered orally, once daily	Placebo n=87 Participants Participants received matching placebo; administered orally, once daily
Percentage Change From Baseline in Hemolysis Measures	1.6 Percentage Change Standard Error 3.68	-4.6 Percentage Change Standard Error 3.69	3.0 Percentage Change Standard Error 3.75

Adverse Events

Voxelotor 900 mg

Serious events: 20 serious events

Other events: 85 other events

Deaths: 2 deaths

Voxelotor 1500 mg

Serious events: 25 serious events

Other events: 85 other events

Deaths: 2 deaths

Placebo

Serious events: 23 serious events

Other events: 81 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Margaret Tonda, PharmD, Sr. Director, Clinical Science

Global Blood Therapeutics

Phone: (650) 741-7761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Voxelotor 900 mg n=92 participants at risk Participants received voxelotor 900 mg, administered orally, once daily	Voxelotor 1500 mg n=88 participants at risk Participants received voxelotor 1500 mg administered orally, once daily	Placebo n=91 participants at risk Participants received matching placebo; administered orally, once daily
Nervous system disorders Headache	21.7% 20/92 • Number of events 22 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	30.7% 27/88 • Number of events 33 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	25.3% 23/91 • Number of events 34 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Diarrhoea	18.5% 17/92 • Number of events 24 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	22.7% 20/88 • Number of events 22 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	11.0% 10/91 • Number of events 12 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	15.2% 14/92 • Number of events 24 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	20.5% 18/88 • Number of events 33 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	14.3% 13/91 • Number of events 17 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Nausea	18.5% 17/92 • Number of events 21 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	18.2% 16/88 • Number of events 21 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	9.9% 9/91 • Number of events 17 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	13.0% 12/92 • Number of events 25 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	17.0% 15/88 • Number of events 17 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	13.2% 12/91 • Number of events 16 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Blood and lymphatic system disorders Anaemia	6.5% 6/92 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.5% 4/88 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.2% 2/91 • Number of events 2 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Abdominal pain	14.1% 13/92 • Number of events 15 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	14.8% 13/88 • Number of events 17 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	11.0% 10/91 • Number of events 12 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Vomiting	14.1% 13/92 • Number of events 20 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	12.5% 11/88 • Number of events 17 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	16.5% 15/91 • Number of events 24 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Abdominal pain upper	15.2% 14/92 • Number of events 19 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	9.1% 8/88 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	6.6% 6/91 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Constipation	9.8% 9/92 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	6.8% 6/88 • Number of events 7 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	9.9% 9/91 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Gastrointestinal disorders Gastritis	5.4% 5/92 • Number of events 7 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	3.4% 3/88 • Number of events 8 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.4% 4/91 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
General disorders Pain	16.3% 15/92 • Number of events 27 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	17.0% 15/88 • Number of events 27 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	19.8% 18/91 • Number of events 22 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
General disorders Fatigue	14.1% 13/92 • Number of events 16 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	13.6% 12/88 • Number of events 14 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	13.2% 12/91 • Number of events 15 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
General disorders Pyrexia	10.9% 10/92 • Number of events 13 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	12.5% 11/88 • Number of events 13 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.4% 4/91 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
General disorders Non-cardiac chest pain	14.1% 13/92 • Number of events 15 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	10.2% 9/88 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	11.0% 10/91 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Hepatobiliary disorders Ocular icterus	9.8% 9/92 • Number of events 15 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	6.8% 6/88 • Number of events 7 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	8.8% 8/91 • Number of events 14 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Upper respiratory tract infection	23.9% 22/92 • Number of events 26 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	13.6% 12/88 • Number of events 13 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	14.3% 13/91 • Number of events 18 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Urinary tract infection	5.4% 5/92 • Number of events 8 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	10.2% 9/88 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	14.3% 13/91 • Number of events 15 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Tonsillitis	3.3% 3/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.7% 5/88 • Number of events 7 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	8.8% 8/91 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Malaria	2.2% 2/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.7% 5/88 • Number of events 8 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	3.3% 3/91 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Influenza	4.3% 4/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	3.4% 3/88 • Number of events 3 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.5% 5/91 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Infections and infestations Gastroenteritis	6.5% 6/92 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.3% 2/88 • Number of events 2 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	3.3% 3/91 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Metabolism and nutrition disorders Decreased appetite	6.5% 6/92 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.3% 2/88 • Number of events 2 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	0.00% 0/91 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Metabolism and nutrition disorders Hypokalaemia	3.3% 3/92 • Number of events 3 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.3% 2/88 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.5% 5/91 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Pain in extremity	21.7% 20/92 • Number of events 33 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	13.6% 12/88 • Number of events 19 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	20.9% 19/91 • Number of events 22 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.3% 4/92 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	6.8% 6/88 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.4% 4/91 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Bone pain	1.1% 1/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.7% 5/88 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	8.8% 8/91 • Number of events 22 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/92 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.3% 2/88 • Number of events 3 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	5.5% 5/91 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Nervous system disorders Dizziness	8.7% 8/92 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.5% 4/88 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	9.9% 9/91 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 6/92 • Number of events 7 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	9.1% 8/88 • Number of events 10 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	11.0% 10/91 • Number of events 11 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 1/92 • Number of events 1 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	8.0% 7/88 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	1.1% 1/91 • Number of events 1 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.4% 5/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	2.3% 2/88 • Number of events 2 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.4% 4/91 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Skin and subcutaneous tissue disorders Rash	5.4% 5/92 • Number of events 5 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	6.8% 6/88 • Number of events 9 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	8.8% 8/91 • Number of events 8 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.
Skin and subcutaneous tissue disorders Pruritus	5.4% 5/92 • Number of events 8 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	4.5% 4/88 • Number of events 4 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.	3.3% 3/91 • Number of events 6 • 72 Weeks Non-sickle cell disease (Non-SCD) related Adverse Events.