Trial Outcomes & Findings for Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis (NCT NCT01084148)

Last Updated: 2017-12-20

Results Overview

Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin 1. = patches of fine, powdery scales 2. = diffuse ashy appearance with many fine scales 3. = moderate scaling with beginning cracks 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

237 participants

Primary outcome timeframe

28 days

Results posted on

2017-12-20

Participant Flow

Among the 237 enrolled patients: one patient not randomized. Among the 118 patients randomized into the V0034CR01B arm, one patient not treated. As such, among the 237 enrolled patients, 235 were treated, ie received test product at least once

Participant milestones

Participant milestones
Measure	V0034CR01B cream V0034CR01B	V0034 CR 01B Vehicle cream V0034CR01B vehicle
Overall Study STARTED	118	118
Overall Study Treated Patients	118	117
Overall Study COMPLETED	88	102
Overall Study NOT COMPLETED	30	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V0034CR01B n=118 Participants cream V0034CR01B	V0034 CR 01B Vehicle n=117 Participants cream V0034CR01B vehicle	Total n=235 Participants Total of all reporting groups
Age, Continuous	64.8 years n=5 Participants	64.5 years n=7 Participants	64.65 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	53 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	64 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: One patient in V0034 CR 01B Vehicle arm randomized but not treated

Outcome measures

Outcome measures
Measure	V0034CR01B n=118 Participants cream V0034CR01B	V0034 CR 01B Vehicle n=117 Participants cream V0034CR01B vehicle
Treatment Response of Xerosis	71 participants	48 participants

SECONDARY outcome

Timeframe: 133 days

At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows : 1. = very satisfactory 2. = satisfactory 3. = poorly satisfactory 4. = not satisfactory at all

Outcome measures

Outcome measures
Measure	V0034CR01B n=118 Participants cream V0034CR01B	V0034 CR 01B Vehicle n=117 Participants cream V0034CR01B vehicle
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B Very satistactory	68 participants	77 participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B Satisfactory	26 participants	32 participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B Poorly satisfactory	5 participants	4 participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B Not satisfactory at all	6 participants	1 participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B No answer	13 participants	3 participants

Adverse Events

V0034CR01B

Serious events: 16 serious events

Other events: 40 other events

Deaths: 0 deaths

V0034 CR 01B Vehicle

Serious events: 19 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Project Manager

Orfagen

Phone: 0033 5 34 50 64 62

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Mutual agreement
Publication restrictions are in place

Restriction type: OTHER

Measure	V0034CR01B n=118 participants at risk cream V0034CR01B	V0034 CR 01B Vehicle n=117 participants at risk cream V0034CR01B vehicle
General disorders Death	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Cellulitis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Sepsis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Dialysis device complication	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications fracture	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Shunt Thrombosis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Spinal compression fracture	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disseminated large cell lymphoma	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Nervous system disorders Cerebrovascular accident	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Nervous system disorders Syncope	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Catheter removal	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Parathyroidectomy	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Renal transplant	3.4% 4/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Vascular disorders Aortic rupture	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Cardiac disorders Acute myocardial infarction	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Cardiac disorders Bradycardia	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Cardiac disorders Coronary artery disease	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Cardiac disorders Left ventricular failure	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Colitis	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Peritonitis	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Necrosis	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Hepatobiliary disorders Jaundice	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Catheter related infection	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Gangrene	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Gastroenteritis	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Osteomyelitis acute	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Arteriovenous fistula anevrysm	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Nervous system disorders Transient ischaemic attack	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Evidence based treatment	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	3.4% 4/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Hospitalisation	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	4.3% 5/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Therapeutic procedure	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.

Measure	V0034CR01B n=118 participants at risk cream V0034CR01B	V0034 CR 01B Vehicle n=117 participants at risk cream V0034CR01B vehicle
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Haemodialysis-induces symptom	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Herpes simplex	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Herpes zoster	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Metabolism and nutrition disorders Fluid retention	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Abdominal pain	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Blood and lymphatic system disorders Anaemia	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Cardiac disorders Angina pectoris	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Ankle fracture	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Psychiatric disorders Anxiety	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Application site erythema	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Application site irritation	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Application site pruritus	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Application site reaction	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Application site vesicles	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Surgical and medical procedures Arteriovenous fistule operation	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Bacillus infection	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Musculoskeletal and connective tissue disorders Back pain	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Investigations Blood pressure increased	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Bronchitis	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Catheter site infection	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Catheter site pruritus	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders catheter site related reaction	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Clavicule fracture	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Respiratory, thoracic and mediastinal disorders Cough	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Nervous system disorders Diabetic neuropathy	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Diarrhoea	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Dry skin	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Dyshidrosis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Renal and urinary disorders Dysuria	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Erysipelas	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	1.7% 2/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Eye infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Vascular disorders Hypertension	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	2.6% 3/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Vascular disorders Hypotension	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
General disorders Inflammation	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Psychiatric disorders Insomnia	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Localised infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Nail infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Nasopharyngitis	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Oesophagitis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Musculoskeletal and connective tissue disorders Pain in extremity	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Paronychia	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Pneumonia	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Post-traumatic pain	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Pruritus	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Pruritus allergic	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Skin and subcutaneous tissue disorders Pruritus generalised	1.7% 2/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Sinusitis	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Skin infection	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Psychiatric disorders Sleep disorder	0.00% 0/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Upper respiratory tract infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Urinary track infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	3.4% 4/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Gastrointestinal disorders Vomiting	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.85% 1/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.
Infections and infestations Wound infection	0.85% 1/118 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.	0.00% 0/117 Among the 118 patients randomized into the V0034CR01B arm, one patient not treated.