Trial Outcomes & Findings for Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001 (NCT NCT01369615)
NCT ID: NCT01369615
Last Updated: 2015-09-09
Results Overview
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Results posted on
2015-09-09
Participant Flow
First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.
Opioid-experienced pediatric patients with moderate to severe malignant and/or nonmalignant pain requiring around-the-clock opioid therapy were eligible for open-label Extension Study OTR3002 if they completed the 4-week treatment period Core Study OTR3001 and could benefit from continued treatment with oxycodone HCl CR 20 to 240 mg total daily.
Participant milestones
| Measure |
6 to < 12 Years
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
6 to < 12 Years
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Baseline characteristics by cohort
| Measure |
6 to < 12 Years
n=9 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=14 Participants
Children 12 to ≤ 16 years of age
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.49 • n=7 Participants
|
12.6 years
STANDARD_DEVIATION 2.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).Population: The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Outcome measures
| Measure |
6 to < 12 Years
n=9 Participants
Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
|
≥ 12 to ≤ 16 Years
n=14 Participants
Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
|
|---|---|---|
|
The Number of Participants With Adverse Events as a Measure of Safety.
Serious adverse events
|
3 participants
|
2 participants
|
|
The Number of Participants With Adverse Events as a Measure of Safety.
All other adverse events in ≥ 5% of patients
|
8 participants
|
8 participants
|
Adverse Events
6 to < 12 Years
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
≥ 12 to ≤ 16 Years
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
6 to < 12 Years
n=9 participants at risk
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=14 participants at risk
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
Other adverse events
| Measure |
6 to < 12 Years
n=9 participants at risk
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=14 participants at risk
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Ear and labyrinth disorders
External ear pain
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Eye disorders
Conjunctivitis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Eye disorders
Eye pain
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Eye disorders
Mydriasis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
14.3%
2/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Pyrexia
|
33.3%
3/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
14.3%
2/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Cyst
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Inflammation
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Mucosal inflammation
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
General disorders
Pain
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Immune system disorders
Drug hypersensitivity
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Oral candidiasis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Haemoglobin decreased
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Blood magnesium decreased
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Oxygen saturation decreased
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Respiratory rate
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Nervous system disorders
Sedation
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Scar
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Surgical and medical procedures
Scar excision
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
7.1%
1/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
0.00%
0/14 • Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
|
Additional Information
Clinical Leader
Purdue Pharma L.P.
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60