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| ID | Type | Description | Link |
|---|---|---|---|
| C1231001 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:
The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 | biosimilar infliximab |
| |
| Remicade | infliximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 | Drug | biosimilar infliximab |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Characteristics of Participants: Disease Duration | Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline). | Baseline (Day 1) |
| Number of Participants Who Switched Treatment | Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported. | From baseline to follow-up period (up to a maximum duration of 2 years) |
| Reasons for Switching Treatment by Participants | From baseline to follow-up period (up to a maximum duration of 2 years) | |
| Total Dose of Infusion Received | Total dose of infusion received by the participants was calculated. | From baseline to follow-up period (up to a maximum duration of 2 years) |
| Number of Participants by Frequency of Infusion Received | Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories. | Baseline (Day 1) |
| Number of Participants Who Had Change in Infusion Dose | Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Remaining in Clinical Remission or Relapse | Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with CT-P13 or Remicade at the time of study enrolment. This would include the following treatment subgroups:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Campus Gasthuisberg | Leuven | Vlaams Brabant | 3000 | Belgium | ||
| UZ Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37038897 | Derived | Bokemeyer B, Hlavaty T, Allez M, Selema P, Moosavi S, Cadatal MJ, Fowler H, Mueller M, Liau KF, Gisbert JP. Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD). Expert Opin Biol Ther. 2023 Jul-Dec;23(8):791-800. doi: 10.1080/14712598.2023.2200883. Epub 2023 Apr 16. |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 2565 participants were enrolled in the study, out of which 22 participants were not eligible to receive treatment for any of the treatment groups. Hence, only those participants who received treatment during the study observation period were included in the participants flow section.
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P13 | Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2017 | Oct 22, 2019 |
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| Remicade | Drug | infliximab |
|
| From baseline to follow-up period (up to a maximum duration of 2 years) |
| Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change | Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest [AESI]/ serious adverse event [SAE]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category. | From baseline to follow-up period (up to a maximum duration of 2 years) |
| Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) | From baseline to follow-up period (up to a maximum duration of 2 years) |
| Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events. | From baseline to follow-up period (up to a maximum duration of 2 years) |
| Months 6, 12, 18 and 24 |
| Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission | HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than [<] 5), mild disease (MD) (score equal to [=] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than [>] 16). | Baseline, Months 6, 12, 18 and 24 |
| Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity | HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16). | Baseline, Months 6, 12, 18 and 24 |
| Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission | Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6). | Baseline, Months 6, 12, 18 and 24 |
| Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity | Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6). | Baseline, Months 6, 12, 18 and 24 |
| Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis | The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing. | At Baseline |
| Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location | The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted. | Baseline, Months 6, 12, 18 and 24 |
| Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity | The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae. | Baseline, Months 6, 12, 18 and 24 |
| Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent | The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC. | Baseline, Months 6, 12, 18 and 24 |
| Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity | The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily). | Baseline, Months 6, 12, 18 and 24 |
| Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index | The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity. | Baseline, Months 6, 12, 18 and 24 |
| Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24 | C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement. | Baseline, Months 6, 12, 18 and 24 |
| Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24 | Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin. | Baseline, Months 6, 12, 18, and 24 |
| Number of Participants With Imaging Test Results | Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported. | From baseline up to follow-up period (a maximum of 2 years) |
| Edegem |
| 2650 |
| Belgium |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o | Hradec Králové | 500 12 | Czechia |
| Centrum péce o zažívací trakt, Vítkovická nemocnice | Ostrava - Vitkovice | 703 84 | Czechia |
| IKEM (Institut Klinické a Experimentální Medicíny) | Prague | 140 21 | Czechia |
| Nemocnice Na Bulovce | Praha 8 Liben | 180 81 | Czechia |
| Keski-Suomen keskussairaala | Jyväskylä | FI-40620 | Finland |
| Oulu University Hospital | Oulu | 90220 | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| CHU Amiens | Amiens | 80054 | France |
| CHU Angers | Angers | 49933 | France |
| CHRU de Besancon | Besançon | 25030 | France |
| Centre Hospitalier Universitaire | Caen | 14033 | France |
| Clinique de Bercy | Charenton | 94220 | France |
| CHU Clermontferrand | Clermont-Ferrand | 63003 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hôpital Louis Mourier | Colombes | 92700 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| CHRU | Lille | 59000 | France |
| Hopital Edouard Herriot Pav H | Lyon | 69003 | France |
| Hopital Europeen | Marseille | 13003 | France |
| Hopital Nord | Marseille | 13015 | France |
| CHU | Montpellier | 34295 | France |
| CHU Nimes | Nîmes | 30029/Cedex 9 | France |
| Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie | Paris | 75012 | France |
| Hopital Cochin | Paris | 75014 | France |
| Institut Montsouris | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hopital St Louis | Paris | 75475 | France |
| CHU Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital Metz Tessy | Pringy | 74374 | France |
| Hopital Robert Debre | Reims | 51000 | France |
| Chu Ch.Nicolle | Rouen | 76031 | France |
| Service: CHU saint-etienne | Saint Priez En Jarez | 42270 | France |
| Centre Hospitalier Universitaire | Strasbourg | 67098 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Hopital Purpan | Toulouse | 31059 | France |
| CHU Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| Groupe hospitalier mutualiste les portes du Sud | Vénissieux | 69694 | France |
| St. Marienkrankenhaus | Ludwigshafen am Rhein | Gartenstadt | 67076 | Germany |
| Gemeinschaftspraxis im MEDICUM | Altenholz | 24161 | Germany |
| Gastroenterologische Praxis Dr. med. B. Adami | Alzey | 55232 | Germany |
| Studienzentrum Aschaffenburg | Aschaffenburg | 63739 | Germany |
| Gastroenterologie Am Bayerischen Platz | Berlin | 10825 | Germany |
| Kreiskliniken Altotting-Burghausen | Burghausen | 84489 | Germany |
| Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main | Frankfurt am Main | 60594 | Germany |
| Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner | Friedrichsthal | 66299 | Germany |
| PraxisZentrum fuer Gastroenterologie | Grevenbroich | 41515 | Germany |
| Hamburgisches Forschungsinstitut fur chronisch entzuendliche | Hamburg | 20148 | Germany |
| Gastroenterologische Gemeinschaftspraxis Herne | Herne | 44623 | Germany |
| Internisten am Markt Dres. Schwerdtfeger & Lehmann | Köthen | 06366 | Germany |
| Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen | Leipzig | 04229 | Germany |
| Onco Studies an der Onkologie Dreiländereck | Loerrach | 79539 | Germany |
| Universitaetsmedizin Mannheim | Mannheim | 68135 | Germany |
| Magen-Darm Praxis Prof. Dr. Krammer & Kollegen | Mannheim | 68165 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Praxis Prof.Dr. med. Herbert Kellner | Muenchen-Nymphenburg | 80639 | Germany |
| Medizinisches Versorgungszentrum Portal 10 | Münster | 48155 | Germany |
| Gastroenterologische Gemeinschaftspraxis am Germania-Campus | Münster | 48159 | Germany |
| Praxiszentrum Alte Maelzerei | Regensburg | 93053 | Germany |
| Magen-Darm-Zentrum Remscheid | Remscheid | 42859 | Germany |
| Zentrum für Gastroenterologie Saarbrücken MVZ GmbH | Saarbrücken | 66111 | Germany |
| Ambulanzzentrum-Schweinfurt | Schweinfurt | 97421 | Germany |
| Gastroenterologische Schwerpunktpraxis Stuttgart | Stuttgart | 70178 | Germany |
| University Hospital of Patras | Rio, Patra | Achaia | 265 04 | Greece |
| Hippokration General Hospital of Athens | Athens | Attica | 11527 | Greece |
| Venizeleio Hospital of Heraklion | Heraklion | Crete | 71409 | Greece |
| Evangelismos Hospital | Athens | 10676 | Greece |
| University Hospital of Ioannina | Ioannina | 455 00 | Greece |
| University Hospital of Larissa | Larissa | 41110 | Greece |
| General Hospital of Thessaloniki Ippokrateio | Thessaloniki | 54642 | Greece |
| Semmelweis University | Budapest | H-1088 | Hungary |
| MH Egeszsegugyi Kozpont - Honvedkorhaz | Budapest | H-1134 | Hungary |
| Szte szent-gyorgyi albert klinikai kozpont | Szeged | H-6725 | Hungary |
| Presidio Ospedaliero "M. Raimondi" | San Cataldo (Caltanisetta) | Caltanisetta | 93100 | Italy |
| ASL 11 Empoli - Ospedale San Giuseppe | Empoli | FI | 50053 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | FI | 50134 | Italy |
| I.R.C.C.S. Policlinico San Donato | San Donato Milanese | Milano | 20097 | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | PR | 43126 | Italy |
| Ospedale "Sacro Cuore - Don Calabria" | Negrar | Verona | 27024 | Italy |
| Fondazione Poliambulanza - Istituto Ospedaliero | Brescia | 25124 | Italy |
| Azienda Ospedaliera per l'Emergenza Cannizzaro | Catania | 95100 | Italy |
| Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele" | Catania | 95123 | Italy |
| Università degli Studi "G. d'Annunzio" Chieti - Pescara | Chieti | 66100 | Italy |
| ASUR Area Vasta n. 4 - Ospedale A. Murri | Fermo | 63900 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Università degli Studi di Genova | Genova | 16132 | Italy |
| A.O.U. Policlinico "G.Martino" | Messina | 98125 | Italy |
| Azienda Ospedaliera - Universitaria di Modena Policlinico | Modena | 41124 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo | 90127 | Italy |
| Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello | Palermo | 90146 | Italy |
| AOUP - Ospedale di Cisanello | Pisa | 56124 | Italy |
| Azienda Ospedaliera Universitaria di PISA | Pisa | 56124 | Italy |
| Ospedale Generale Provinciale di Macerata | Province of Macerata | 62100 | Italy |
| Ospedale Sandro Pertini | Roma | 00157 | Italy |
| Ospedale San Camillo | Rome | 00152 | Italy |
| A.O.U. "S. Maria della Misericordia di Udine" | Udine | 33100 | Italy |
| Ziekenhuis Gelderse Vallei | Ede | 6716 RP | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 | Netherlands |
| Rijnstate | Gelderland | 6815 AD | Netherlands |
| Hospital Prof. Doutor Fernando Fonseca E.P.E | Amadora | Lisbon District | 2720-276 | Portugal |
| Centro Hospitalar entre Douro e Vouga E.P.E. | Santa Maria Da Feira | Porto District | 4520-211 | Portugal |
| Centro Hospitalar Barreiro Montijo, E.P.E | Barreiro | 2830-003 | Portugal |
| Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| FNsP F. D. Roosevelta Banska Bystrica | Banská Bystrica | 974 01 | Slovakia |
| V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia | Bratislava | 826 06 | Slovakia |
| Hospital Arquitecto Marcide | Ferrol | A Coruna | 15405 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Son Espases | Palma. Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | Barcelona | 17007 | Spain |
| Hospital de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Galdakao | Usansolo | Bizkaia | 48960 | Spain |
| Hospital Universitario de Gran Canaria DR NEGRIN | Las Palmas de Gran Canari | Canary Islands | 35010 | Spain |
| Hospital de Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Universitario Infanta Sofia | San Sebastian de Los Reye | Madrid | 28702 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Alvaro Cunqueiro | Pontevedra | 36312 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| Consorci Hospital General Universitari de Valencia | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Royal Gwent Hospital | Exeter | Devon | EX2 5DW | United Kingdom |
| Dorset County Hospital | Dorchester | Dorset | DT1 2JY | United Kingdom |
| Gloucestershire Hospitals - NHS Foundation Trust | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
| Cwm Taf University Health Board | Llantrisant | Wales | CF72 8XR | United Kingdom |
| University Hospital Coventry | Coventry | WEST Midlands | CV2 2DX | United Kingdom |
| Salisbury NHS Foundation Trust | Salisbury | Wiltshire | SP2 8BJ | United Kingdom |
| Heart of England NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| The Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Queen Alexandra Hospital | Hampshire | PO6 3LY | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| FG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| FG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| FG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| FG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT-P13 | Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. |
| BG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| BG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| BG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| BG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Participants With Medical History of Smoking | Count of Participants | Participants |
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| Participants With a History of Cancer | Count of Participants | Participants |
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| Participants With Stoma Status | Count of Participants | Participants |
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| Participants With a History Surgery | Surgery status was a categorical variable defined as yes if the participant had prior surgical treatment related to the treatment of CD or UC. | Count of Participants | Participants |
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| Participants With a History of Fistula Disease | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease Characteristics of Participants: Disease Duration | Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline). | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | months | Baseline (Day 1) |
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| Primary | Number of Participants Who Switched Treatment | Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Posted | Count of Participants | Participants | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Reasons for Switching Treatment by Participants | Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analyzed. | Posted | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Total Dose of Infusion Received | Total dose of infusion received by the participants was calculated. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | milligram | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Number of Participants by Frequency of Infusion Received | Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) |
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| Primary | Number of Participants Who Had Change in Infusion Dose | Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Posted | Count of Participants | Participants | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change | Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest [AESI]/ serious adverse event [SAE]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Posted | Count of Participants | Participants | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Primary | Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events. | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Posted | Count of Participants | Participants | From baseline to follow-up period (up to a maximum duration of 2 years) |
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| Secondary | Number of Participants Remaining in Clinical Remission or Relapse | Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. | Full analysis set (FAS)=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC).Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Months 6, 12, 18 and 24 |
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| Secondary | Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission | HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than [<] 5), mild disease (MD) (score equal to [=] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than [>] 16). | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity | HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16). | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission | Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6). | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity | Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6). | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis | The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified rows for each arm. | Posted | Count of Participants | Participants | At Baseline |
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| Secondary | Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location | The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity | The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent | The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity | The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily). | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index | The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm. | Posted | Count of Participants | Participants | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24 | C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement. | FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24 | Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin. | FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm. | Posted | Mean | Standard Deviation | milligram per kilogram (mg/kg) | Baseline, Months 6, 12, 18, and 24 |
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| Secondary | Number of Participants With Imaging Test Results | Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported. | FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). | Posted | Count of Participants | Participants | From baseline up to follow-up period (a maximum of 2 years) |
|
From baseline to follow-up period (up to a maximum duration of 2 years)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P13 | Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. | 4 | 1,522 | 256 | 1,522 | 442 | 1,522 |
| EG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. | 2 | 494 | 43 | 494 | 100 | 494 |
| EG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. | 1 | 358 | 57 | 358 | 90 | 358 |
| EG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. | 0 | 67 | 10 | 67 | 7 | 67 |
| EG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. | 0 | 102 | 15 | 102 | 21 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Bicytopenia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Cardiovascular disorder | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Steroid withdrawal syndrome | Endocrine disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fistula of small intestine | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal anastomotic stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Adhesion | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Administration site extravasation | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Paradoxical drug reaction | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Stenosis | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lupus hepatitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cryptosporidiosis infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| CSF pressure | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug specific antibody present | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Angiomyolipoma | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthritis enteropathic | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Muscle rupture | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sarcopenia | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Seminoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Meningioma | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | Non-systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Kidney congestion | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cervix carcinoma | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Caesarean section | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Colectomy | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ventriculo-peritoneal shunt | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Behcet's syndrome | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Femoral artery embolism | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Neurosensory hypoacusis | Ear and labyrinth disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Scleritis | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal anastomotic stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pouchitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dysplasia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fibrosis | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Type I hypersensitivity | Immune system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Genital herpes zoster | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ophthalmic herpes simplex | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Papilloma viral infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Parvovirus B19 infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ureteritis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Blood count abnormal | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Colonoscopy | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug specific antibody present | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Mean cell volume decreased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cell death | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malignant melanoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Meningioma | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gestational trophoblastic detachment | Pregnancy, puerperium and perinatal conditions | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rebound psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intestinal resection | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2018 | Oct 22, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591237 | CT-P13 |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
|
|
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 |
| Remicade |
Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 |
| Remicade |
Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG001 | Remicade | Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| Remicade |
Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. |
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
|
|
| OG002 | Switched From Remicade to CT-P13 | Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG003 | Switched From CT-P13 to Remicade | Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. |
| OG004 | Multiple Switchers | Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. |
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| Relapse |
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| L2 Colon |
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| L3 Ileocolon |
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| L4 Upper GI |
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| L1 Terminal ileum, L4 Upper GI |
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| L2 Colon, L4 Upper GI |
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| L3 Ileocolon, L4 Upper GI |
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| Missing |
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| B2 Stricturing |
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| B3 Penetrating |
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| p Perianal disease |
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| B2 Stricturing, B3 Penetrating |
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| B1 NS,NP, p Perianal disease |
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| B2 Stricturing, p Perianal disease |
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| B2 Stricturing, B3 Penetrating, p Perianal disease |
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| B3 Penetrating, p Perianal disease |
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| Missing |
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| E2 Left-sided UC |
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| E3 Extensive UC |
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| Missing |
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| S1 |
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| S2 |
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| S3 |
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| Missing |
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| Improvement |
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| Worsened |
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| Unchanged |
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| Not accessible |
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| Missing |
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