| Primary | Percentage of Participants With One or More Treatment Intensifications for CD Participants | Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Logistic | p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW). | =0.13202 | | Odds Ratio (OR) | 0.61 | | | 2-Sided | 95 | 0.32 | 1.16 | | | Estimated with a logistic regression adjusted by PS-IPTW. | | Superiority | | |
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| Primary | Percentage of Participants With One or More Treatment Intensifications for UC Participants | Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Number of Participants With Reasons for Treatment Modifications in CD Participants | Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable for specified categories of this outcome measure. | Posted | | Count of Participants | | Participants | | From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha |
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| Primary | Number of Participants With Reasons for Treatment Modifications in UC Participants | Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure and "number analyzed" signified participants who were evaluable for specified categories of this outcome measure. | Posted | | Count of Participants | | Participants | | From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants Who Discontinued Index Therapy for CD Participants | Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
|
| Primary | Percentage of Participants Who Discontinued Index Therapy for UC Participants | Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha | Participants diagnosed with UC, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab, golimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| Primary | Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation | Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group. | Posted | | Count of Participants | | Participants | | From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: CD Participants, Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Time to Switching for Vedolizumab Participants | Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab [UC only], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group. | Posted | | Median | Inter-Quartile Range | months | | From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: CD Participants, Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Time to Discontinuation for CD Participants | Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | months | | From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Time to Discontinuation for UC Participants | Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | months | | From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Percentage of Participants With Clinical Response at 14 Weeks for CD Participants | Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (<=) 4 or reduction of greater than or equal to (>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the statistical analysis plan (SAP), the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window 10 to 18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Percentage of Participants With Clinical Response at 52 Weeks for CD Participants | Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of <=4 or reduction of >=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 46 to 58 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Response at 14 Weeks for UC Participants | Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (<) 4 or reduction of >= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window 10 to 18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Response at 52 Weeks for UC Participants | Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of <4 or reduction of >= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 46 to 58 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants | Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of <=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window 10 to 18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants | Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of <=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 46 to 58 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants | Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of <2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window 10 to 18 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants | Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of <2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 46 to 58 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
|
| Primary | Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants | Biochemical remission based on CRP was defined as CRP level of <5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window >0 to 38 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants | Biochemical remission based on CRP was defined as CRP level of <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants | Biochemical remission based on CRP was defined as CRP level <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window >0 to 38 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants | Biochemical remission based on CRP was defined as CRP level of <5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants | Biochemical remission based on FCP was defined as FCP level of <250 microgram per gram (mcg/g). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window >0 to 38 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants | Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants | Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside >0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 14 weeks post-index (assessment time window >0 to 38 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants | Biochemical remission based on FCP was defined as FCP level of <250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Primary | Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants | Endoscopic response for CD participants was evaluated using simple endoscopic index for Crohn's disease (SES-CD) score. SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD score <=2 or based on physician assessment (for UC and CD both). SES-CD score at index date >0 relative difference was calculated (100*[Index date-52 weeks assessment]/Index date) and relative difference of >= 50% was considered response. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants | Endoscopic response in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1: Vedolizumab | Participants diagnosed with UC or CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2: Anti-TNF Alpha | |
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| Primary | Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants | Endoscopic remission for CD participants was evaluated using SES-CD score. The SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD score <=2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. |
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| Primary | Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants | Endoscopic remission in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure. | All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | At 52 weeks post-index (assessment time window 28 to 76 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, UC Participants: Vedolizumab | Participants diagnosed with UC, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of UC diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, UC Participants: Anti-TNF Alpha |
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| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. The PS-IPTW method was used for balancing the cohorts. Percentage of participants determined after applying this method are reported in 'Adverse events' and 'Serious adverse events' categories in this outcome measure. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | |
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| Secondary | Incidence Rate of Adverse Events and Serious Adverse Events | Incidence rate was based on per 100 participants-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | events per 100 participant-years | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
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| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| Secondary | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with treatment related adverse events and related treatment serious adverse events were reported. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| Secondary | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | events per 100 participant-years | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| Secondary | Percentage of Participants With Infections, Serious Infections and Malignancies | Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with infections, serious infections and malignancies were reported. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | percentage of participants | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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| Secondary | Incidence Rate of Infections, Serious Infections and Malignancies | Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. | All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. | Posted | | Number | | events per 100 participant-years | | Index event period up to 6 months post-index treatment discontinuation | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1, CD Participants: Vedolizumab | Participants diagnosed with CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then in post-index event period from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when vedolizumab treatment was initiated. | | OG001 | Cohort 2, CD Participants: Anti-TNF Alpha | Participants diagnosed with CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab), between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period from the date of CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then in post-index event period from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date was defined as the date when other biologic treatment was initiated. |
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