Trial Outcomes & Findings for A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers (NCT NCT02154425)

NCT ID: NCT02154425

Last Updated: 2018-04-03

Results Overview

Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 17 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2018-04-03

Participant Flow

The study started to enroll patients in September 2014 and concluded in December 2015.

The Participant Flow refers to the Safety Set which consisted of 18 mothers, who were screened and had received at least one dose of Certolizumab Pegol (CZP), but only 17 mothers entered the study (Enrollment number), as one subject was a screen failure.

Participant milestones

Measure	Mothers (SS) This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
Screening Period STARTED	18
Screening Period COMPLETED	17
Screening Period NOT COMPLETED	1
Sampling Period STARTED	17
Sampling Period COMPLETED	17
Sampling Period NOT COMPLETED	0

Reasons for withdrawal

Measure	Mothers (SS) This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
Screening Period Adverse Event	1

Baseline Characteristics

A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

Baseline characteristics by cohort

Measure	Mothers (SS) n=18 Participants This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous arithmetic mean (standard deviation)	33.7 years STANDARD_DEVIATION 4.2 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 0

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0	NA µg/mL Interval to 0.0571 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 2

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2	NA µg/mL Interval to 0.0686 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 4

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4	0.03578 µg/mL Interval to 0.0742 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 6

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6	0.03739 µg/mL Interval to 0.0758 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 8

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8	0.03899 µg/mL Interval to 0.0755 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 10

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10	NA µg/mL Interval to 0.0685 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 12

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12	NA µg/mL Interval to 0.0694 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 14

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=16 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14	NA µg/mL Interval to 0.0603 NA = below limit of quantification.	NA µg/mL NA = below limit of quantification.

PRIMARY outcome

Timeframe: Day 28

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28	NA µg/mL NA = below limit of quantification.	—

PRIMARY outcome

Timeframe: Day 2

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2	0 mg/kg/day Interval 0.0 to 0.0103	—

PRIMARY outcome

Timeframe: Day 4

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4	0.005306 mg/kg/day Interval 0.0 to 0.0111	—

PRIMARY outcome

Timeframe: Day 6

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6	0.005604 mg/kg/day Interval 0.0 to 0.0114	—

PRIMARY outcome

Timeframe: Day 8

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8	0.005606 mg/kg/day Interval 0.0 to 0.0113	—

PRIMARY outcome

Timeframe: Day 10

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10	0 mg/kg/day Interval 0.0 to 0.0103	—

PRIMARY outcome

Timeframe: Day 12

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12	0 mg/kg/day Interval 0.0 to 0.0104	—

PRIMARY outcome

Timeframe: Day 14

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14	0 mg/kg/day Interval 0.0 to 0.00904	—

PRIMARY outcome

Timeframe: Day 28

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.

In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=1 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28	0 mg/kg/day Interval 0.0 to 0.0	—

PRIMARY outcome

Timeframe: From Day 0 to Day 14 or 28

Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.

Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.

Outcome measures

Measure	Mothers CZP (PK-PPS) Q2W n=17 Participants This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).	Mothers CZP (PK-PPS) Q4W This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)	0.003503 mg/kg/day Interval 0.0 to 0.0104	—

Adverse Events

SS-M

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

SS-I

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	SS-M n=18 participants at risk This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).	SS-I n=17 participants at risk This arm consisted of all infants of mothers in the SS-M.
Infections and infestations Breast abscess	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)

Other adverse events

Measure	SS-M n=18 participants at risk This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).	SS-I n=17 participants at risk This arm consisted of all infants of mothers in the SS-M.
Gastrointestinal disorders Exacerbation of Crohn's disease	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Upper respiratory tract infection	11.1% 2/18 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	17.6% 3/17 • Number of events 3 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Candida infection	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	5.9% 1/17 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Herpes zoster	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Viral upper respiratory tract infection	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Nervous system disorders Headache	11.1% 2/18 • Number of events 2 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Reproductive system and breast disorders Galactostasis	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Reproductive system and breast disorders Nipple disorder	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	0.00% 0/17 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/18 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	5.9% 1/17 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Gastrointestinal disorders Vomiting	0.00% 0/18 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	5.9% 1/17 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Infections and infestations Nasopharyngitis	0.00% 0/18 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	23.5% 4/17 • Number of events 4 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)
Skin and subcutaneous tissue disorders Lichen striatus	0.00% 0/18 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)	5.9% 1/17 • Number of events 1 • Adverse Events were collected during the whole study period (from Week 0 to Week 19)

Additional Information

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Phone: +1877 822

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60