Trial Outcomes & Findings for Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application (NCT NCT02459418)
NCT ID: NCT02459418
Last Updated: 2018-06-29
Results Overview
AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
COMPLETED
PHASE1
42 participants
From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.
2018-06-29
Participant Flow
This was a Phase 1, randomised, open label, 2-period, 2-treatment, crossover study in healthy female subjects. 42 subjects were randomised to receive either AFOLIA on study day 1 and Gonal-f® RFF on study day 27 or Gonal-f® RFF on study day 1 and AFOLIA on study day 27.
Screening was conducted at more than 1 visit to the clinical unit during study days -28 to -1 to allow completion of all assessments. Only subjects taking oral contraception for at least 3 months could enter the study. Subjects were required to stop taking their regular oral contraceptives so they could receive LupronDepot®.
Participant milestones
| Measure |
AFOLIA Then Gonal-f® RFF
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single subcutaneous (s.c.) dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® intramuscular (i.m.) injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF, on study day 27. Exit examinations were performed on study day 35.
|
Gonal-f® RFF Then AFOLIA
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27. Exit examinations were performed on study day 35.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
Received First Treatment
|
21
|
21
|
|
Overall Study
Received Second Treatment
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
AFOLIA Then Gonal-f® RFF
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single subcutaneous (s.c.) dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® intramuscular (i.m.) injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF, on study day 27. Exit examinations were performed on study day 35.
|
Gonal-f® RFF Then AFOLIA
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27. Exit examinations were performed on study day 35.
|
|---|---|---|
|
Overall Study
Exclusion Criteria
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Endometrial thickness of >5 mm
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Elevated Creatine Kinase
|
1
|
0
|
|
Overall Study
Abnormal Transvaginal Ultrasound
|
1
|
0
|
Baseline Characteristics
Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Baseline characteristics by cohort
| Measure |
AFOLIA Then Gonal-f® RFF
n=21 Participants
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 International Units (IU) AFOLIA, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation, 225 IU Gonal-f® RFF on study day 27.
Exit examinations were performed on study day 35.
|
Gonal-f® RFF Then AFOLIA
n=21 Participants
On study day -1 (10 days after administration of LupronDepot®) subjects were assessed for eligibility of treatment by confirmation of down regulation of endogenous FSH levels. If down regulation was not confirmed the evaluation may have been repeated up to 7 days later.
Period 1: On study day 1, eligible subjects received a single s.c. dose of the first FSH preparation, 225 IU Gonal-f® RFF, in the abdomen. On study day 16, subjects received a second LupronDepot® i.m. injection.
Period 2: On study day 26, subjects underwent a further FSH down regulation assessment. This evaluation was repeated up to 7 days later if required and if down regulation was not confirmed after the second evaluation, the subject was no longer able to continue in the study. If eligibility was confirmed, the subject received the alternative FSH preparation of 225 IU AFOLIA on study day 27.
Exit examinations were performed on study day 35.
|
Total
n=42 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
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 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
|
27.8 years
n=5 Participants
|
28.1 years
n=7 Participants
|
28.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.Population: Analysis was performed on the Pharmacokinetic Analysis Set (PKAS) which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.
AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=36 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=33 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]
|
18.96 nanograms*hours/mL (ng*h/mL)
Interval 2.2 to 73.2
|
10.47 nanograms*hours/mL (ng*h/mL)
Interval 0.288 to 42.8
|
PRIMARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.
Cmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=36 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=34 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected FSH Maximum Serum Concentration (Cmax)
|
0.4795 ng/mL
Interval 0.21 to 1.13
|
0.3692 ng/mL
Interval 0.048 to 1.17
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of AUC(0-∞) are included.
AUC(0-∞) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=18 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=12 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected FSH Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)]
|
27.88 ng*h/mL
Interval 10.8 to 76.0
|
20.57 ng*h/mL
Interval 6.43 to 49.0
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.
Tmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods.
Outcome measures
| Measure |
AFOLIA
n=36 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=34 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected Time to Reach Maximum FSH Serum Concentration (Tmax)
|
24.05 hours
Interval 6.0 to 28.03
|
16 hours
Interval 3.0 to 28.08
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of terminal half-life are included.
Apparent terminal half-life was defined as ln2/apparent terminal rate constant (λz). λz is determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment was used to identify the terminal linear phase of the baseline corrected concentration-time profile. A minimum of 3 data points was used for determination. Terminal half-life was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=18 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=12 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected FSH Apparent Terminal Half-life
|
20.4 hours
Interval 7.76 to 62.0
|
18.02 hours
Interval 7.37 to 61.4
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.
AUC(0-last) was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=34 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=31 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected 17ß-Estrodiol (E2) Serum Exposure AUC(0-last)
|
888 pg*h/mL
Interval 12.4 to 13800.0
|
570 pg*h/mL
Interval 7.6 to 11700.0
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.
Cmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF.
Outcome measures
| Measure |
AFOLIA
n=34 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=34 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected E2 Cmax
|
28.03 pg/mL
Interval 3.5 to 227.1
|
15.95 pg/mL
Interval 0.1 to 171.0
|
SECONDARY outcome
Timeframe: From 0 hours (predose) to 192 hours postdose.Population: This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.
Tmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration. Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods.
Outcome measures
| Measure |
AFOLIA
n=34 Participants
All subjects who received the test product 225 IU AFOLIA and had at least 1 measured concentration at a scheduled pharmacokinetic (PK) or pharmacodynamic (PD) time point after administration of AFOLIA.
|
Gonal-f® RFF
n=34 Participants
All subjects who received the test product 225 IU Gonal-f® RFF and had at least 1 measured concentration at a scheduled PK or PD time point after administration of Gonal-f® RFF.
|
|---|---|---|
|
Baseline Corrected E2 Tmax
|
47.92 hours
Interval 22.0 to 96.0
|
27.5 hours
Interval 20.0 to 144.5
|
Adverse Events
AFOLIA
Gonal-f® RFF
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AFOLIA
n=36 participants at risk
This analysis set contained all subjects who received one dose of AFOLIA (225 IU).
|
Gonal-f® RFF
n=34 participants at risk
This analysis set contained all subjects who received one dose of Gonal-f® RFF (225 IU).
|
|---|---|---|
|
Vascular disorders
Hot flush
|
30.6%
11/36 • Number of events 11 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
32.4%
11/34 • Number of events 11 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Vascular disorders
Haematoma
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
0.00%
0/34 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/36 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Nervous system disorders
Headache
|
11.1%
4/36 • Number of events 5 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
29.4%
10/34 • Number of events 12 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Nervous system disorders
Dizziness
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
General disorders
Catheter site related reaction
|
0.00%
0/36 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
|
Infections and infestations
Rhinitis
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contract agreement. Results may not be published or referred to, in whole or in part, without the prior express written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER