Trial Outcomes & Findings for Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897) (NCT NCT01190267)

NCT ID: NCT01190267

Last Updated: 2024-05-22

Results Overview

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a "treatment-emergent" AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

204 participants

Primary outcome timeframe

Up to 30 weeks

Results posted on

2024-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Asenapine - Participants Who Were ≤17 Years Old In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Overall Study STARTED	196	8
Overall Study COMPLETED	155	4
Overall Study NOT COMPLETED	41	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Asenapine - Participants Who Were ≤17 Years Old In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Overall Study Adverse Event	10	0
Overall Study Treatment Failure	8	2
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	13	1
Overall Study Protocol Violation	8	1

Baseline Characteristics

Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asenapine - Participants Who Were ≤17 Years Old n=196 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old n=8 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.	Total n=204 Participants Total of all reporting groups
Age, Continuous	15.3 years STANDARD_DEVIATION 1.5 • n=5 Participants	18 years STANDARD_DEVIATION 0 • n=7 Participants	15.4 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	4 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	4 Participants n=7 Participants	126 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 weeks

Population: All participants who received at least one dose of extension study medication

Outcome measures

Outcome measures
Measure	Asenapine - Participants Who Were ≤17 Years Old n=196 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old n=8 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study	114 participants	3 participants

PRIMARY outcome

Timeframe: Up to 26 weeks

Population: All participants who received at least one dose of extension study medication

Outcome measures

Outcome measures
Measure	Asenapine - Participants Who Were ≤17 Years Old n=196 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old n=8 Participants In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE	10 participants	0 participants

Adverse Events

Asenapine - Participants Who Were ≤17 Years Old

Serious events: 7 serious events

Other events: 59 other events

Deaths: 0 deaths

Asenapine - Participants Who Were 18 Years Old

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Asenapine - Participants Who Were ≤17 Years Old n=196 participants at risk In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old n=8 participants at risk In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
General disorders MULTI-ORGAN FAILURE	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Psychiatric disorders AGGRESSION	1.0% 2/196 • Number of events 2 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Psychiatric disorders AGITATION	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Psychiatric disorders ANXIETY	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Psychiatric disorders SCHIZOPHRENIA	1.5% 3/196 • Number of events 3 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee It is planned to first publish/present trial results together with the other sites, unless permission is obtained from Sponsor to publish separate results. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. If there is disagreement concerning appropriateness of the materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve disagreement prior to submission for publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Asenapine - Participants Who Were ≤17 Years Old n=196 participants at risk In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.	Asenapine - Participants Who Were 18 Years Old n=8 participants at risk In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
Eye disorders VISION BLURRED	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
General disorders FATIGUE	2.6% 5/196 • Number of events 5 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
General disorders FEELING COLD	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
General disorders PAIN	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	1.5% 3/196 • Number of events 4 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 3 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Injury, poisoning and procedural complications INJURY	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders AKATHISIA	2.0% 4/196 • Number of events 4 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders BRADYKINESIA	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders COGWHEEL RIGIDITY	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders HEADACHE	6.6% 13/196 • Number of events 18 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders HYPOAESTHESIA	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders RESTING TREMOR	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders SEDATION	5.1% 10/196 • Number of events 11 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 3 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders SOMNOLENCE	14.8% 29/196 • Number of events 36 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	0.00% 0/8 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Nervous system disorders TREMOR	2.0% 4/196 • Number of events 4 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Psychiatric disorders SUICIDAL IDEATION	1.5% 3/196 • Number of events 3 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 2 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT CONGESTION	0.00% 0/196 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).
Skin and subcutaneous tissue disorders ACNE	0.51% 1/196 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).	12.5% 1/8 • Number of events 1 • Up to 30 weeks The serious adverse events (SAEs) table includes all SAEs that occurred during this extension study. The Other AEs table includes only AEs in study that were "treatment-emergent" (i.e., not present at the extension study baseline, or present at the extension study baseline but worsened in severity compared to baseline during the extension study).