Trial Outcomes & Findings for Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids (NCT NCT01192295)
NCT ID: NCT01192295
Last Updated: 2020-03-23
Results Overview
Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
155 participants
Primary outcome timeframe
Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Results posted on
2020-03-23
Participant Flow
First Patient First Visit: 28-Feb-2011; Last Patient Last Visit: 29-Jul-2014. The study was conducted at medical/research sites in the United States, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand
Participant milestones
| Measure |
6 to < 12 Years
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
128
|
|
Overall Study
COMPLETED
|
17
|
105
|
|
Overall Study
NOT COMPLETED
|
10
|
23
|
Reasons for withdrawal
| Measure |
6 to < 12 Years
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
5
|
|
Overall Study
Administrative
|
4
|
6
|
Baseline Characteristics
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Baseline characteristics by cohort
| Measure |
6 to < 12 Years
n=27 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=128 Participants
Children ≥ 12 to ≤ 16 years of age
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 1.34 • n=7 Participants
|
13.7 years
STANDARD_DEVIATION 2.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=5 Participants
|
88 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 participants
n=5 Participants
|
31 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.
Outcome measures
| Measure |
6 to < 12 Years
n=27 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=128 Participants
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
The Number of Participants With Adverse Events as a Measure of Safety.
Serious adverse events
|
5 participants
|
22 participants
|
|
The Number of Participants With Adverse Events as a Measure of Safety.
All other adverse events in ≥ 5% of patients
|
13 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
Pain right now was assessed by patients aged 6 to \<12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.
Outcome measures
| Measure |
6 to < 12 Years
n=27 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 1: evening
|
4.07 units on a scale
Standard Deviation 2.695
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 2: evening
|
3.70 units on a scale
Standard Deviation 2.686
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 4: evening
|
3.42 units on a scale
Standard Deviation 2.974
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Baseline
|
4.44 units on a scale
Standard Deviation 3.250
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 1: morning
|
4.11 units on a scale
Standard Deviation 2.674
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 2: morning
|
3.66 units on a scale
Standard Deviation 2.640
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 3: morning
|
3.64 units on a scale
Standard Deviation 2.579
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 3: evening
|
3.76 units on a scale
Standard Deviation 2.669
|
—
|
|
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Average during week 4: morning
|
3.13 units on a scale
Standard Deviation 2.569
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.
Outcome measures
| Measure |
6 to < 12 Years
n=128 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 1: evening
|
39.24 units on a scale
Standard Deviation 23.301
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 2: evening
|
33.04 units on a scale
Standard Deviation 24.778
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 3: evening
|
33.46 units on a scale
Standard Deviation 24.639
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 4: morning
|
35.58 units on a scale
Standard Deviation 27.177
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 1: morning
|
40.38 units on a scale
Standard Deviation 24.402
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 2: morning
|
34.49 units on a scale
Standard Deviation 24.980
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 3: morning
|
32.56 units on a scale
Standard Deviation 25.802
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Average during week 4: evening
|
35.30 units on a scale
Standard Deviation 26.711
|
—
|
|
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Baseline
|
44.58 units on a scale
Standard Deviation 28.291
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.
Outcome measures
| Measure |
6 to < 12 Years
n=27 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=128 Participants
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Use of Supplemental Pain Medication
Any supplemental pain medication
|
24 participants
|
112 participants
|
|
Use of Supplemental Pain Medication
Any opioid supplemental pain medication
|
21 participants
|
93 participants
|
|
Use of Supplemental Pain Medication
Any nonopioid supplemental pain medication
|
17 participants
|
75 participants
|
SECONDARY outcome
Timeframe: Baseline to week 4 or early discontinuationPopulation: The safety population was the group of patients who received at least 1 dose of study drug during the study.
The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.
Outcome measures
| Measure |
6 to < 12 Years
n=25 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=115 Participants
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
7 = Very much worse
|
1 participants
|
1 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
4 = No change
|
3 participants
|
5 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
1 = Very much improved
|
10 participants
|
42 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
2 = Much improved
|
8 participants
|
51 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
3 = Minimally improved
|
3 participants
|
15 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
5 = Minimally worse
|
0 participants
|
1 participants
|
|
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
6 = Much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.
Outcome measures
| Measure |
6 to < 12 Years
n=27 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
Baseline
|
27.1 units on a scale
Standard Deviation 13.06
|
—
|
|
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
Week 4
|
23.0 units on a scale
Standard Deviation 13.32
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: The safety population was the group of patients who received at least 1 dose of study drug during the study.
The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.
Outcome measures
| Measure |
6 to < 12 Years
n=128 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
Baseline
|
23.2 units on a scale
Standard Deviation 17.47
|
—
|
|
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
Week 4
|
20.4 units on a scale
Standard Deviation 12.65
|
—
|
SECONDARY outcome
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]Population: Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio. The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state).
Outcome measures
| Measure |
6 to < 12 Years
n=105 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmin - last dose
|
6.35 ng/mL
Interval 2.34 to 22.0
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmin,ss - first dose
|
7.73 ng/mL
Interval 2.9 to 28.8
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmax - first dose
|
16.3 ng/mL
Interval 7.82 to 58.2
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmax - last dose
|
15.8 ng/mL
Interval 7.87 to 59.5
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmin - first dose
|
6.86 ng/mL
Interval 2.69 to 23.1
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmin,ss - last dose
|
7.46 ng/mL
Interval 2.47 to 28.9
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmax,ss - first dose
|
20.9 ng/mL
Interval 9.23 to 66.1
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Cmax,ss - last dose
|
17.9 ng/mL
Interval 9.46 to 68.4
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
CAVGss - first dose
|
16.1 ng/mL
Interval 6.84 to 53.7
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
CAVGss - last dose
|
15.7 ng/mL
Interval 6.77 to 58.9
|
—
|
SECONDARY outcome
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]Population: Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours. The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state).
Outcome measures
| Measure |
6 to < 12 Years
n=105 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
AUCtau - first dose
|
181 ng*hour/mL
Interval 74.2 to 562.0
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
AUCtau - last dose
|
158 ng*hour/mL
Interval 77.2 to 545.0
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
AUCss - first dose
|
194 ng*hour/mL
Interval 82.1 to 645.0
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
AUCss - last dose
|
188 ng*hour/mL
Interval 81.3 to 707.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]Population: Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose.
Outcome measures
| Measure |
6 to < 12 Years
n=105 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
Tmax - first dose
|
3.75 Hours
Interval 2.5 to 5.75
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
Tmax - last dose
|
3.75 Hours
Interval 2.5 to 5.75
|
—
|
SECONDARY outcome
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]Population: Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau).
Outcome measures
| Measure |
6 to < 12 Years
n=105 Participants
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
Accumulation ratio - first dose
|
1.14 Ratio
Interval 1.03 to 1.4
|
—
|
|
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
Accumulation ratio - last dose
|
1.14 Ratio
Interval 1.03 to 1.42
|
—
|
Adverse Events
6 to < 12 Years
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
≥ 12 to ≤ 16 Years
Serious events: 22 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
6 to < 12 Years
n=27 participants at risk
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=128 participants at risk
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • 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.
|
3.1%
4/128 • 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
Neutropenia
|
7.4%
2/27 • 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.
|
0.78%
1/128 • 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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.7%
1/27 • 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%
0/128 • 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%
0/27 • 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.
|
0.78%
1/128 • 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
Vertigo
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Diplopia
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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%
0/27 • 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.
|
0.78%
1/128 • 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%
0/27 • 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.
|
0.78%
1/128 • 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
Pancreatitis acute
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
|
3.7%
1/27 • 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%
0/128 • 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%
0/27 • 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.
|
1.6%
2/128 • 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
|
0.00%
0/27 • 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.
|
1.6%
2/128 • 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
|
7.4%
2/27 • 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.
|
3.9%
5/128 • 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
Gangrene
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Gastroenteritis clostridial
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Osteomyelitis
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Post procedural cellulitis
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/27 • 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.
|
1.6%
2/128 • 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
|
3.7%
1/27 • 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%
0/128 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Balance disorder
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Coma
|
3.7%
1/27 • 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.
|
0.78%
1/128 • 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
Convulsion
|
3.7%
1/27 • 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%
0/128 • 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
Dizziness
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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%
0/27 • 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.
|
1.6%
2/128 • 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
Lethargy
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Status migrainosus
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Hypoxia
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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 disorder
|
3.7%
1/27 • 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%
0/128 • 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
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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
Axillary vein thrombosis
|
0.00%
0/27 • 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.
|
0.78%
1/128 • 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=27 participants at risk
Children 6 to \< 12 years of age
|
≥ 12 to ≤ 16 Years
n=128 participants at risk
Children ≥ 12 to ≤ 16 years of age
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
22.2%
6/27 • 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.
|
20.3%
26/128 • 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%
3/27 • 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.
|
15.6%
20/128 • 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
|
14.8%
4/27 • 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.
|
9.4%
12/128 • 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
|
18.5%
5/27 • 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.
|
6.2%
8/128 • 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%
3/27 • 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.
|
13.3%
17/128 • 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
Dizziness
|
0.00%
0/27 • 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.
|
8.6%
11/128 • 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%
3/27 • 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.
|
5.5%
7/128 • 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