Trial Outcomes & Findings for Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee (NCT NCT02205814)

NCT ID: NCT02205814

Last Updated: 2015-11-03

Results Overview

The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

436 participants

Primary outcome timeframe

from baseline up to 2 weeks after randomisation

Results posted on

2015-11-03

Participant Flow

The first patient was screened on 28th April 2014. The first patient was randomised on 6th May 2014. The last patient completed the study on 6th January 2015. The study was conducted in 25 study sites in Czech Republic, Germany, Italy and US.

A total of 645 patients entered a 2-week Screening period (including wash out); 209 of them were screen failed. One patient randomised to PLACEBO did not receive the study treatment (counted for ITT but not in safety population). Five patients received the study treatment without randomisation (not counted for ITT, but in safety population).

Participant milestones

Participant milestones
Measure	Fasitibant Low Dose Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Overall Study STARTED	110	110	108	108
Overall Study COMPLETED	108	109	103	104
Overall Study NOT COMPLETED	2	1	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Fasitibant Low Dose Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Lack of Efficacy	1	0	1	1
Overall Study Physician Decision	0	0	1	0
Overall Study Protocol Violation	1	0	0	1
Overall Study Withdrawal by Subject	0	1	2	1
Overall Study not compliant with study procedures	0	0	1	0

Baseline Characteristics

Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fasitibant Low Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=107 Participants Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=108 Participants Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo	Total n=431 Participants Total of all reporting groups
Age, Continuous Age	65.3 years STANDARD_DEVIATION 7.61 • n=5 Participants	63.2 years STANDARD_DEVIATION 8.73 • n=7 Participants	64.7 years STANDARD_DEVIATION 8.43 • n=5 Participants	64.4 years STANDARD_DEVIATION 8.50 • n=4 Participants	64.4 years STANDARD_DEVIATION 8.34 • n=21 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	71 Participants n=7 Participants	64 Participants n=5 Participants	66 Participants n=4 Participants	263 Participants n=21 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	37 Participants n=7 Participants	43 Participants n=5 Participants	42 Participants n=4 Participants	168 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=5 Participants	108 Participants n=7 Participants	106 Participants n=5 Participants	106 Participants n=4 Participants	427 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
BMI	27.1 kg/m2 STANDARD_DEVIATION 2.12 • n=5 Participants	26.5 kg/m2 STANDARD_DEVIATION 2.83 • n=7 Participants	27.1 kg/m2 STANDARD_DEVIATION 2.35 • n=5 Participants	27.0 kg/m2 STANDARD_DEVIATION 2.60 • n=4 Participants	26.9 kg/m2 STANDARD_DEVIATION 2.50 • n=21 Participants
WOMAC A	286.5 units on a scale STANDARD_DEVIATION 40.4 • n=5 Participants	282.7 units on a scale STANDARD_DEVIATION 40.08 • n=7 Participants	278.3 units on a scale STANDARD_DEVIATION 38.11 • n=5 Participants	275.5 units on a scale STANDARD_DEVIATION 39.81 • n=4 Participants	280.8 units on a scale STANDARD_DEVIATION 39.61 • n=21 Participants
WOMAC INDEX	1321.5 units on a scale STANDARD_DEVIATION 278.88 • n=5 Participants	1275.4 units on a scale STANDARD_DEVIATION 283.60 • n=7 Participants	1282.6 units on a scale STANDARD_DEVIATION 274.50 • n=5 Participants	1293.5 units on a scale STANDARD_DEVIATION 239.73 • n=4 Participants	1293.3 units on a scale STANDARD_DEVIATION 269.35 • n=21 Participants
EQ VAS	63.1 units on a scale STANDARD_DEVIATION 20.54 • n=5 Participants	64.3 units on a scale STANDARD_DEVIATION 17.21 • n=7 Participants	67.4 units on a scale STANDARD_DEVIATION 18.18 • n=5 Participants	65.7 units on a scale STANDARD_DEVIATION 19.47 • n=4 Participants	65.1 units on a scale STANDARD_DEVIATION 18.89 • n=21 Participants

PRIMARY outcome

Timeframe: from baseline up to 2 weeks after randomisation

Population: The primary efficacy analysis was performed on the ITT-population (n=431).

Outcome measures

Outcome measures
Measure	Fasitibant Low Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=107 Participants Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=108 Participants Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Change in WOMAC A Week 1 after randomisation	-91.8 units on a scale Standard Deviation 101.85	-110.0 units on a scale Standard Deviation 99.48	-109.8 units on a scale Standard Deviation 94.65	-93.7 units on a scale Standard Deviation 94.15
Change in WOMAC A Week 2 after randomisation	-106.1 units on a scale Standard Deviation 101.88	-131.5 units on a scale Standard Deviation 96.41	-115.9 units on a scale Standard Deviation 104.61	-117.2 units on a scale Standard Deviation 90.15

SECONDARY outcome

Timeframe: from baseline up to 6 weeks after randomisation

Population: The secondary efficacy analysis was performed on the ITT population (n=431).

The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.

Outcome measures

Outcome measures
Measure	Fasitibant Low Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=107 Participants Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=108 Participants Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Change in WOMAC INDEX Week 1 after randomisation	-396.0 units on a scale Standard Deviation 464.24	-460.5 units on a scale Standard Deviation 469.68	-445.2 units on a scale Standard Deviation 424.07	-413.2 units on a scale Standard Deviation 452.04
Change in WOMAC INDEX Week 2 after randomisation	-448.0 units on a scale Standard Deviation 477.95	-563.0 units on a scale Standard Deviation 456.71	-488.7 units on a scale Standard Deviation 480.39	-517.7 units on a scale Standard Deviation 440.75
Change in WOMAC INDEX week 4 after randomisation	-516.4 units on a scale Standard Deviation 513.70	-628.4 units on a scale Standard Deviation 500.17	-493.4 units on a scale Standard Deviation 513.94	-562.3 units on a scale Standard Deviation 487.25
Change in WOMAC INDEX Week 6 after randomisation	-566.3 units on a scale Standard Deviation 525.63	-653.8 units on a scale Standard Deviation 516.31	-547.6 units on a scale Standard Deviation 522.37	-581.3 units on a scale Standard Deviation 503.37

SECONDARY outcome

Timeframe: from baseline up to 6 weeks after randomisation

Population: The secondary efficacy variables were analysed in the ITT population (n=431).

Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.

Outcome measures

Outcome measures
Measure	Fasitibant Low Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=107 Participants Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=108 Participants Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Responder Rate According to OMERACT-OARSI Criteria Week 1 after randomisation	51.9 percentage of responders	56.5 percentage of responders	63.6 percentage of responders	55.6 percentage of responders
Responder Rate According to OMERACT-OARSI Criteria Week 2 after randomisation	59.3 percentage of responders	72.2 percentage of responders	62.6 percentage of responders	68.5 percentage of responders
Responder Rate According to OMERACT-OARSI Criteria Week 4 after randomisation	65.7 percentage of responders	72.2 percentage of responders	65.4 percentage of responders	66.7 percentage of responders
Responder Rate According to OMERACT-OARSI Criteria Week 6 after randomisation	71.3 percentage of responders	74.1 percentage of responders	67.3 percentage of responders	67.6 percentage of responders

SECONDARY outcome

Timeframe: from baseline up to 6 weeks after randomisation

Population: The secondary efficacy analysis was performed on the ITT-population (n=431).

Response based on change ≥ 20 % from baseline for EQ-5D-5L index value

Outcome measures

Outcome measures
Measure	Fasitibant Low Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=108 Participants Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=107 Participants Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=108 Participants Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate Week 6 after randomisation	23.1 percentage of responders	27.8 percentage of responders	25.2 percentage of responders	21.3 percentage of responders
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate Week 2 after randomisation	18.5 percentage of responders	18.5 percentage of responders	20.6 percentage of responders	24.1 percentage of responders

Adverse Events

Fasitibant Low Dose

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Fasitibant Intermediate Dose

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Fasitibant High Dose

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

PLACEBO

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fasitibant Low Dose n=110 participants at risk Drug: solution for intra-articular injection Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant	Fasitibant Intermediate Dose n=110 participants at risk Drug: solution for intra-articular injection Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant	Fasitibant High Dose n=108 participants at risk Drug: solution for intra-articular injection Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant	PLACEBO n=107 participants at risk Drug: solution for intra-articular injection Placebo comparator: Single intra-articular injection of placebo
Gastrointestinal disorders Inguinal hernia	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/108 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Infections and infestations Urinary tract infection	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/108 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/107 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.91% 1/110 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.91% 1/110 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Investigations Hepatic enzyme increased	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/107 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/107 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/107 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.91% 1/110 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Surgical and medical procedures Hernia repair	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/108 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Surgical and medical procedures Knee arthroplasty	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.93% 1/107 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Surgical and medical procedures Malignant breast lump removal	0.91% 1/110 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.91% 1/110 • Number of events 1 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/110 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/108 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	0.00% 0/107 • For all patients receiving the study treatment (safety population, N=435), adverse event data were collected over a period of maximal 15 weeks. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Other adverse events

Additional Information

Angela Capriati, MD PhD - Corporate Director Clinical Research

MENARINI Group

Phone: +39 055 5680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to submitting the results of this study for publication or presentation, the Investigator will allow the sponsor at least 30 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the sponsor has reviewed/commented and agreed to any publication.
Publication restrictions are in place

Restriction type: OTHER