| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00010.6(6.1 to 15.1)
- OG0010.0(0.0 to 0.0)
|
|
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| Secondary | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Adolescent Users |
|
| 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 | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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 | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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 | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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 | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days | | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days | | 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. | Posted | | | | | | From first purchase of study drug (Day 1) to Day 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|