Pain
Conditions
Brief summary
This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, at-risk consumers, as discussed with the FDA, will comprise elderly consumers (\>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.
Interventions
Ibuprofen 600 mg Immediate Release/Extended Release Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male or female 18 years of age or older, has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months, and qualifies for inclusion in at least one risk group category, including cardiovascular, gastrointestinal bleeding, history of severe pain (≥5 episodes in last month) or \>65 years of age (see Groups 1 4 in Section 3.1). OR Male or female 12-17 years of age and has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months. 2. Evidence of a personally signed and dated informed consent document (ICD), and in the case of minor adolescent subjects (12-17 years of age or adolescent subjects residing in states where the age of majority is \> than 18), an assent document, indicating that the subject and where applicable a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. 3. Willing and able to comply with scheduled visits, treatment plan, and other study procedures. 4. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to purchase study medication. 5. Agrees the product purchased is for subject's own use and not to be shared. 6. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to provide contact information for follow up purposes.
Exclusion criteria
Subjects with any of the following characteristics/conditions will not be included in the study: 1. Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand English. 2. Trained or employed as a healthcare professional. 3. Subject or someone else in the household is employed by a pharmaceutical company, medical practice or hospital, pharmacy, managed care or health insurance organization or a contract research organization. 4. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or potential subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. 5. Participation in other studies involving investigational drug(s) within 6 months prior to study entry and/or during study participation. 6. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs. 7. Subjects with the following clinical conditions which place them at excessively high risk or have ≥20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic Cardiovascular Risk, will not be included in the study: clinically established coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non fatal cardiovascular disease event (angina, heart failure, heart disease, heart attack, stroke/transient ischemic attack) or have had heart surgery or who currently have uncontrolled high blood pressure (either by self report or by measured systolic blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the time of the enrollment interview), will also be excluded from the study. 8. Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring hospitalization or blood transfusion. 9. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product (IP) administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Pregnant female subjects; breastfeeding female subjects; and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the end of their 30-Day Use Phase or, for subjects who use the investigational product after Day 30, 28 days after the last recorded dose of investigational product. 11. 18 years of age or older and classified as normal literacy (REALM Test score ≥61) after the normal literacy group quotas (approximately 70% of adult subjects) are full or refuses to complete the REALM Test (note there is no corresponding literacy exclusion criterion for adolescent subjects based on REALM Teen score). 12. 18 years of age or older and classified as moderate (less frequent) oral OTC pain reliever user (\<30 doses per month on average in the preceding 3 months) after the moderate user group quotas (approximately 33% of adult subjects) are full. 13. Not capable of swallowing a vitamin sized tablet. 14. Refuses to participate in required assessments (such as urine pregnancy, finger stick cholesterol or blood pressure tests, or unable or unwilling to comply with electronic diary procedures). The following additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | From first purchase of study drug (Day 1) to Day 30 | Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | From first purchase of study drug (Day 1) to Day 30 | Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | From first purchase of study drug (Day 1) to Day 30 | Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | From first purchase of study drug (Day 1) to Day 30 | Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 10 consecutive days. |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 10 consecutive days. |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 10 consecutive days. |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 10 consecutive days. |
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 7 consecutive days. |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 7 consecutive days. |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 7 consecutive days. |
| Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day | From first purchase of study drug (Day 1) to Day 30 | More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day. |
| Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day | From first purchase of study drug (Day 1) to Day 30 | More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day. |
| Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day | From first purchase of study drug (Day 1) to Day 30 | More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day. |
| Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day | From first purchase of study drug (Day 1) to Day 30 | More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day. |
| Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days | From first purchase of study drug (Day 1) to Day 30 | — |
| Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | From first purchase of study drug (Day 1) to Day 30 | Participants did not need to necessarily use the study medication for 7 consecutive days. |
| Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
| Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | From first purchase of study drug (Day 1) to Day 30 | Use period was defined as 30 days from purchase. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult Compliance-Evaluable Population The participants included in this group were male or female of age \>=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (\>=5 episodes in last month) or \>65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use. | 198 |
| Adolescent Users The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use. | 5 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Did not meet risk classification group criteria | 90 | 0 |
| Overall Study | Did not qualify at re-screening and medical conditions | 133 | 0 |
| Overall Study | Did not sign consent | 17 | 0 |
| Overall Study | Lost to Follow-up | 6 | 0 |
| Overall Study | Not returned to sign consent, download electronic diary application or to purchase study medication | 2 | 0 |
| Overall Study | Not willing to purchase study medication | 142 | 0 |
| Overall Study | Other | 4 | 0 |
| Overall Study | Other eligibility criteria not met pre-consent | 22 | 0 |
| Overall Study | Partial missing data | 44 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Adult Compliance-Evaluable Population | Adolescent Users | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 5 Participants | 5 Participants |
| Age, Categorical >=65 years | 48 Participants | 0 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 0 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 1 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 188 Participants | 4 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 137 Participants | 4 Participants | 141 Participants |
| Sex: Female, Male Male | 61 Participants | 1 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 198 | 0 / 5 |
| other Total, other adverse events | 9 / 198 | 1 / 5 |
| serious Total, serious adverse events | 4 / 198 | 0 / 5 |
Outcome results
Primary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 10.6 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Primary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the end-of-study (EOS) interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 7.8 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Primary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 7.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Primary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 2.8 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 30.7 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 20.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 17.9 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Participants did not need to necessarily use the study medication for 10 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 22.9 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 3.4 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Participants did not need to necessarily use the study medication for 7 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 47.5 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 36.3 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 29.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day
More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day | 11.7 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days | 22.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 22.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 20.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 14.5 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Participants did not need to necessarily use the study medication for 10 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 16.2 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 2.2 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Participants did not need to necessarily use the study medication for 7 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 43.0 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 28.5 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 19.6 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day
More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day | 7.8 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days | 22.9 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 19.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 20.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 13.4 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Participants did not need to necessarily use the study medication for 10 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 14.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 2.2 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Participants did not need to necessarily use the study medication for 7 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 1.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 42.5 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 26.8 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 17.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day
More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day | 7.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days | 22.9 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 13.4 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 7.8 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Participants did not need to necessarily use the study medication for 10 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 6.1 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 2.2 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Participants did not need to necessarily use the study medication for 7 consecutive days.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 0.6 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 39.7 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 18.4 Percentage of participants |
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 12.3 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <12 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <10 Hours | 0.0 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions | Re-dosed in <8 Hours | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day
More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Compliance-Evaluable Population | Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day | 2.8 Percentage of participants |
| Adolescent Users | Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day | 0.0 Percentage of participants |
Secondary
Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days
Time frame: From first purchase of study drug (Day 1) to Day 30
Population: Data for this outcome measure was not estimable based on the pre-specified mitigation factors, as consecutive use days were not dosing errors and therefore not mitigable. Hence, no results were calculated.