Trial Outcomes & Findings for Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors (NCT NCT00543101)

Last Updated: 2017-07-21

Results Overview

Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as \< 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

24 weeks

Results posted on

2017-07-21

Participant Flow

Five multicenter sites were used these included medical and research clinics.

Participant milestones

Participant milestones
Measure	Switch to DRV/r Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Switch to DRV/r n=12 Participants Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 Participants This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years n=5 Participants	51 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Switch to DRV/r n=12 Participants Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 Participants This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
The Percentage of Participants With Successful Virologic Suppression	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 48 weeks

To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.

Outcome measures

Outcome measures
Measure	Switch to DRV/r n=12 Participants Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 Participants This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Economic Impact of a Substitution of Dual Boosted PIs With DRV/r	217 US dollars savings per month	0 US dollars savings per month

SECONDARY outcome

Timeframe: baseline and 24 weeks

We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.

Outcome measures

Outcome measures
Measure	Switch to DRV/r n=12 Participants Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 Participants This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Lipid Fraction Results, Mean of the Change From Baseline to Week 24. Change in Total Cholesterol	-6 mg/dL NA	2 mg/dL
Lipid Fraction Results, Mean of the Change From Baseline to Week 24. Change in LDL-Cholesterol	-4 mg/dL	2 mg/dL
Lipid Fraction Results, Mean of the Change From Baseline to Week 24. Change in HDL-Cholesterol	-1 mg/dL	1 mg/dL
Lipid Fraction Results, Mean of the Change From Baseline to Week 24. Change in Triglycerides	-13 mg/dL	0 mg/dL

SECONDARY outcome

Timeframe: 24 weeks

Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.

Outcome measures

Outcome measures
Measure	Switch to DRV/r n=12 Participants Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=7 Participants This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) How well does your treatment fit your lifestyle	3 Units on a Scale (+3 to -3) Interval -1.0 to 3.0	3 Units on a Scale (+3 to -3) Interval 2.0 to 3.0
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) How satisfied are your with your current treatment	3 Units on a Scale (+3 to -3) Interval 0.0 to 3.0	2.5 Units on a Scale (+3 to -3) Interval 2.0 to 3.0
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) How satisfied are you with any side-effects	2 Units on a Scale (+3 to -3) Interval 0.0 to 3.0	2.5 Units on a Scale (+3 to -3) Interval 2.0 to 3.0
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) How convenient is your treatment	3 Units on a Scale (+3 to -3) Interval -1.0 to 3.0	3 Units on a Scale (+3 to -3) Interval 2.0 to 3.0
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) Would you recommend your treatment to someone else	3 Units on a Scale (+3 to -3) Interval 0.0 to 3.0	2.5 Units on a Scale (+3 to -3) Interval 2.0 to 3.0
Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now) How likely are you to continue your treatment	3 Units on a Scale (+3 to -3) Interval 0.0 to 3.0	2.5 Units on a Scale (+3 to -3) Interval 1.0 to 3.0

Adverse Events

Switch to DRV/r

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Continue on Current Dual Boosted PI

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Switch to DRV/r n=12 participants at risk Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 participants at risk This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Hepatobiliary disorders Abnormal Total Bilirubin	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Hepatobiliary disorders Bilirubin Grade 3	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Metabolism and nutrition disorders Elevated Triglycerides	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)

Other adverse events

Additional Information

Clavin Cohen MD

Community Research Initiative of New England (CRINE)

Phone: 617 502 1700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Site Investigators (PIs) agree not to individually publish the results of the study. They may participate in a joint publication of the study results with the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Switch to DRV/r n=12 participants at risk Switch to DRV/r at a dose of 600/100 BID for 48 weeks	Continue on Current Dual Boosted PI n=12 participants at risk This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
Skin and subcutaneous tissue disorders anal ulceration	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Vascular disorders bilateral ankle and pedal edema	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Respiratory, thoracic and mediastinal disorders bronchitis	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders chest pain	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Respiratory, thoracic and mediastinal disorders coarse rhonchi bilaterally	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
General disorders cough	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders decreased range of motion, left shoulder/arm	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
General disorders dental	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Psychiatric disorders depression	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Gastrointestinal disorders diarrhea	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
Ear and labyrinth disorders earache	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Vascular disorders elevated blood pressure, intermittent	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations flu	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders fractured sternum	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Metabolism and nutrition disorders gout	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Nervous system disorders intermittent tingling on tongue with metallic taste	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Nervous system disorders intermittent numbness left face/tongue	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations left molar abscess	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders lower back pain	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
General disorders malaise	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Respiratory, thoracic and mediastinal disorders nasal congestion	25.0% 3/12 • Number of events 3 • Adverse events data were collected over the course of the study (about 2 years)	16.7% 2/12 • Number of events 3 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders nose fracture	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders pubic region	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) recurrence of squamous cell carcinoma in situ-colorectal	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders right arm pain (secondary to motor vehicle accident)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders right hip pain (secondary to motor vehicle accident)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders right knee pain (secondary to motor vehicle accident)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Nervous system disorders symptoms of memory loss	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations worsening hepatitis B	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Vascular disorders worsening hypertension	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations abscess posterior right thigh	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Gastrointestinal disorders abdominal pain	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Hepatobiliary disorders abnormal liver function test	33.3% 4/12 • Number of events 6 • Adverse events data were collected over the course of the study (about 2 years)	33.3% 4/12 • Number of events 5 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders anal fissure	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Respiratory, thoracic and mediastinal disorders asthmatic, bronchitis	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Immune system disorders bilateral inguinal lymphadeopathy	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
General disorders body aches	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders body aches	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders broken wrist	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders cellulitis	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Cardiac disorders chest pain	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders contusion, right forehead	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Renal and urinary disorders creatinine	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
Metabolism and nutrition disorders elevated cholesterol	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Metabolism and nutrition disorders elevated glucose	8.3% 1/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Metabolism and nutrition disorders elevated triglycerides	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Eye disorders eye irritation	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
General disorders fatigue	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Vascular disorders headache	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations herpes glands penis	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations herpes simplex UPNI (HSV) on face	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations herpes zoster	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders inflammation penis	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
General disorders insomnia	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Immune system disorders lymphadenopathy	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Nervous system disorders meralgia paresthetica	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Gastrointestinal disorders nausea	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations neuropathic symptoms	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders open wound, finger	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations periodontal disease	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders pruritis	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders pulled hamstring	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations respiratory infection	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders sebaceous cyst	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)
Skin and subcutaneous tissue disorders skin rash	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)	16.7% 2/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations sore throat	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations suprapubic abscess	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)
Infections and infestations viral syndrome	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)	8.3% 1/12 • Number of events 2 • Adverse events data were collected over the course of the study (about 2 years)
Musculoskeletal and connective tissue disorders wrist sprain	8.3% 1/12 • Number of events 1 • Adverse events data were collected over the course of the study (about 2 years)	0.00% 0/12 • Adverse events data were collected over the course of the study (about 2 years)