Clinical Trials Insight is the new standard in rapid evaluation of clinical trial evidence for pharmaceutical professionals. Every year all the clinical trials reported in over 1,700 medical and scientific journals and at major meetings are assessed. An incomparable resource for clinical intelligence, Clinical Trials Insight provides in-depth analysis of every clinical trial, identifies key study messages and evaluates the clinical and commercial impact of the study's results.
CTID is a subset of Clinical Trials Insight with in-depth coverage of diabetes drugs and market performance.
CTID Indications
CTID Drug Groups
The following alphabetical list provides the two-letter label, the relevant alias, and an example for each CTI field.
Note: The fields below do not have Indexing (word or phrase) listed because Index browsing is not available in this database.
===== ============ Label Name/Example ===== ============ aa Adis Assessment [Display Only] The Adis Assessment field (aa) displays the following information: Outcome (OT), Trial Design Score(SC), Score Type, and Positive and Negative Features. Refer to the Outcome (OT) or Trial Design Score (SC) fields for searching information. ad Adis Comment [Word Indexed] nonrandomized.ad. The Adis Comment (AD) field captures data relevant to the study obtained largely from a source/s other than the original article. The comment may include information on the clinical relevance of the study, the development phase of a research drug, commercial drug information, and/or strengths and weaknesses of the study design. All A-rated assessments (clinical relevance rating) contain an added-value Adis Comment. Some B-rated assessments have Adis Comments, and C-rated assessments only have relevant meeting information in the Adis Comment field. ae Adverse Events [Word Indexed] anaemia.ae. depression.ae. The Adverse Events (AE) field captures the important tolerability results. am Author Comments [Word Indexed] galantamine.am. The Author Comments (AM) field contains the author's concluding remarks about the study, usually a quote. an Accession Number [Phrase Indexed] 800011513.an. The Accession Number (AN) field contains a unique number assigned to each record for identification. A record's accession number remains the same throughout the life of the record. at Adis Title [Word Indexed] bacterial.at. The Adis Title (AT) field contains all words found in the Adis title for each record. au Author [Phrase Indexed] smith j.au. The Author (AU) index contains the names of the author(s) of the original article from which a study or case report is taken. The Author (AU) index is browsable. Results display in the Reference (RF) field. cd Case Details [Word Indexed] abnormalities.cd. The Case Details (CD) field contains case information on the disease being treated, the dechallenge, rechallenge, outcome, claimed association, and key details. Not all fields appear in every record. ch Patient Characteristics [Word Indexed] rotator.ch. The Patient Characteristics (CH) field contains relevant data about the study subjects that may affect their response to the intervention. Results display in Patient Characteristics field. cl Study Control [Phrase Indexed] vaccination strategy comparison.cl. baseline comparison.cl. The Study Control (CL) index is a list of terms used to describe the controls used in the study. A study can have more than one type of control. The index is browsable on the Search Fields page. Results display in the Study Details (SD) field. cm Concomitant Medication [Word Indexed] nevirapine.cm. The Concomitant Medication (CM) field is a list of all drugs given concurrently, for example, those that are not the focus of the study. co Company Name [Phrase Indexed] merck.co. The Company Name index contains the names of companies associated with a study as either a sponsor or a co-author or as the marketer/manufacturer of the drug used in a treatment. The Company Name (CO) index is browsable. Results display in either the Study Details (SD) or Treatments (TR) fields. cr Clinical Relevance [Word Indexed] c.cr. Clinical Relevance (CR) rates the significance of the study results on patient care. A 3-point scale (A,B,C) is used and defined as: A Provides new evidence of clinical benefit. B Provides supporting evidence to existing data. C Adds no new or important information. A limit to Clinical Relevance restricts retrieval to only records containing the chosen rating. cy Country [Phrase Indexed] poland.cy. The Country (CY) index contains the location of the country or countries in which the study population lived. The original study report does not always clearly state this fact; in these cases, Adis does not infer the study location from the location of the institution to which the authors are affiliated. The Country (CY) field is browsable. Results display in the Study Details (SD) field. A limit to country restricts retrieval to only records containing the chosen country. de Descriptors [Phrase Indexed] hepatitis.de. bronchitis.de. The Descriptors (DE) field contains the terms for Indications, Therapeutic Areas, Diseases, and Drug Names. The index is browsable. di Disease Index [Word Indexed] pneumonia.di. The Disease Index (DI) contains the names of the disease being treated or prevented. dn Drug Name [Phrase Indexed] docetaxel.dn. ace inhibitors candesartan cilexetil.dn. The Drug Name (DN) index contains the name(s) of the drug(s) used in studies and case reports. The Drug Name (DN) index is browsable. Results display in the Descriptors (DE) field. dt Document Type [Phrase Indexed] study.dt. The Document Type (DT) field consists of the2 types of records found in CTI: study and case. Case reports are used only for adverse reaction case reports or where drug interactions lead to an adverse reaction. A limit to Document Type restricts the search to either study, case, or citation. dw Drug Word [Word Indexed] warfarin.dw. The Drug Word (DW) index contains the name(s) of the drug(s) used in studies and case reports. Results display in the Case Details (CD) field. ep Endpoints [Phrase Indexed] pain intensity difference.ep. The Endpoints (EP) index is used to select studies with particular endpoints as their focus. Endpoints are the important efficacy parameters measured in the study and reported as results. The Endpoints (EP) index is browsable. The results display in the Study Details (SD) field. fn Number of Females ([Phrase Indexed] 30.fn. The Number of Females (FN) index contains the number of females initially enrolled in the study or case. Results display in the Subjects (SU) field. fo Treatment Formulation [Word Indexed] controlled release.fo. The Treatment Formulation (FO) index contains the distinct formulations in which a drug has been administered. This information is not routinely given in the original article and therefore the data is sparse. Results display in the Treatments (TR) field. fr Frequency of Administration [Word Indexed] tid.fr. The Frequency of Administration (FR) index contains the data for how often the drug is administered. The following abbreviations are used: od once daily bid twice daily tid 3 times daily qid 4 times daily q4h every 4 hours 5 day 5 times daily prn as required q3mo every 3 months q4w every 4 weeks d1+8 on days 1 and 8 d1-8 on days 1 through 8 (inclusive) d2+5 q6w on days 2 and 6 every 6 weeks stat at once Results display in the Treatments (TR) or Results Table (RB) field. gd Group Details [Display Only] The Group Details (GD) field contains the number of groups used in the study and the group comparability. The group comparability describes the significant differences that exist between treatment groups, not patient groups, in baseline characteristics that have the potential to affect the results prognostic factors. gn Number of Subject Groups [Phrase Indexed] 22.gn. The Number of Subject Groups (GN) index contains the number of subjects used in a case report or study. The results display in the Group Details (GD) field. hw Heading Words [Word Indexed] hepatitis.hw. The Heading Words (HW) index contains the words for Indications, Therapeutic Areas, Diseases, and Drug Names. ic Indication [Phrase Indexed] pagets disease.ic. The Indication (IC) field contains a list of the diseases being treated, being prevented, or that have been induced by a particular drug. This index is browsable. in Author Institution [Word Indexed] halifax.in. The Author Institution (IN) index contains the name of the institution with which the primary author(s) are affiliated. Results display in the References (RF) field. iw Indication Word [Word Indexed] cancer.iw. The Indication Word (IW) index contains a list of the diseases being treated, being prevented, or that have been induced by a particular drug. Displays in Indication field. jn Journal Name [Phrase Indexed] mayo clinic proceedings.jn. The Journal Name (JN) field contains the full name of the journal in which the original study or case report appeared. The Journal Name (JN) index is browsable. Results display in the Reference (RF) field. jw Journal Word [Word Indexed] medical.jw. The Journal Word (JW) index contains individual words from every journal name in CTI. This field is used to retrieve every occurrence of a journal, which includes a particular word, such as "Medical." lc Latest Change [Phrase Indexed] 19960302.lc. The Latest Change field (LC) indicates the most recent change to the record. mn Number of Males [Phrase Indexed] 13.mn. The Number of Males (MN) index contains the total number of males initially enrolled in the study or case. Results display in the Subjects (SU) field. ms Study Messages [Word Indexed] babies.ms. The Study Messages (MS) are simple statements derived from the study of a basic fact about the treatment. It states the study conclusion/s in qualitative terms. The study conclusions are based on the main results, for example, the results of the stated endpoints and relevant, statistically significant others. These are compulsory for A- and B-rated studies and optional for C's (these studies are less likely to have a clear message). There is a maximum of 6 study messages per assessment. ns Number of Subjects [Phrase Indexed] 101.ns. The Number of Subjects (NS) index contains the total number of subjects used in either the case or study. Results display in the Subjects (SU) field. ot Outcome [Word Indexed] b-poliovirus.ot. The Outcome (OT) index is word indexed. Results display in the Adis Assessment (AA) field. pe Pharmacoeconomic Descriptors [Word Indexed] reimbursement.pe. The Pharmacoeconomic Descriptors (PE) field contains keywords expressing basic pharmacoeconomic concepts. pg Page [Phrase Indexed] 130.pg. The Page (PG) index contains the initial page number from the original article. Results display in the Reference (RF) field. ph Study Phase [Phrase Indexed] phase ii.ph. phase iv.ph. Four phases of clinical trials and drug development exist in the Study Phase (PH) index. Results display in the Study Details field (SD). The four phases are as follows: Phase I Purpose: Determine tolerability and dosage. Initial safety trials on a new medicine, usually conducted in normal male volunteers. An attempt is made to establish the dosage range tolerated by volunteers for single and multiple dosages. As well as the drug's tolerability profile and dosage range, these studies also determine how a drug is absorbed, distributed, metabolised, and excreted, and the duration of its action. Phase II Purpose: Provide a measure of efficacy in addition to short-term tolerability. Phase II studies are conducted in patients who have the disease or condition that the drug is intended to treat. Other Phase II study objectives include determining the minimum dose that is maximally effective, or that is sufficiently effective without undue toxicity. When it is both possible and useful, Phase II studies should be controlled investigations involving a placebo or standard therapy comparator. Phase III Purpose: Confirm efficacy, monitor adverse reactions from long-term use. In Phase III studies, a drug is tested under conditions more closely resembling those under which the drug would be used if approved for marketing. The goal is to gather additional information about efficacy and tolerability that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labelling. Phase IV Purpose: Provide ongoing data after regulatory (e.g. FDA) approval. Phase IV clinical trials are undertaken for reasons such as:
The following limits are available from the Limit menu on the Main Search screen.
*Copyright Adis International 2002*
Sample 1 Accession Number 800799839 Document Type study Adis Title Venlafaxine: therapeutic use Generalised anxiety disorder Effects on somatic and psychic symptoms Adis Comment This study was published as an abstract in the proceedings of the 22nd Collegium International Neuropsychopharmacologicum Congress (CINP) held in Brussels, Belgium in July 2000. Additional information used in this summary was taken from a poster presented at the conference. Study Messages Efficacy: Venlafaxine improves both somatic and psychic symptoms of anxiety in patients with generalised anxiety disorder. Clinical Relevance B Adis Assessment Score Type: efficacy Outcome Efficacy: venlafaxine > placebo Subjects Type: patients Number: 1841 Age: not stated Study Purpose The current diagnostic criteria for generalised anxiety disorder are dominated by psychic symptoms. However, somatic symptoms are an important part of the disorder. The Hamilton Anxiety Rating Scale (HARS) comprises 7 items which measure the psychic symptoms of anxiety and 7 which refer to somatic symptomatology. This study investigated the effects of extended-release venlafaxine on somatic and psychic symptoms in patients with generalised anxiety disorder. Author Comments 'Results from the present analysis support the efficacy of venlafaxine XR [extended-release] in the treatment of GAD [generalised anxiety disorder], and show that somatic and psychic symptoms show similar degrees of improvement following venlafaxine XR treatment. In comparison, patients in the placebo group showed more improvement on somatic than psychic symptoms.' Study Details Design: retrospective Control: placebo comparison Phase: Phase III Country: not stated End Points: Clinical-response-rate, Hamilton-Anxiety-Rating-Scale, Assessment-scale-scores, Clinical-response, Response Company: Wyeth-Ayerst Study Methods Data were pooled from 5 short-term, multicentre, double-blind, placebo- controlled studies. Two of these studies had long-term extension phases of 6 months' duration (n = 767). Treatments Treatment Group: Venlafaxine Group Description: Placebo Treatment: Venlafaxine short-term Duration: 8 weeks Formulation: controlled release Status: launched Treatment: Venlafaxine long-term Duration: 6 months Formulation: controlled release Status: launched Results Highlights Efficacy: In patients with generalised anxiety disorder, similar improvements were observed in somatic and psychic symptoms following treatment with extended- release venlafaxine (p < 0.001 vs placebo). However, patients in the placebo group demonstrated more improvement on somatic symptoms than psychic symptoms. Results Text 16% of patients were considered to be 'somatisers', with a ratio of somatic to psychic HARS factor scores > 1.0. 77% of these patients were somatic responders to venlafaxine after 6 months, compared with 52% in the placebo group (p < 0.01). Response rates in the somatiser population were higher than those seen in the non-somatiser population. Results Table ------------------------------------------------------------------ Efficacy analysis Placebo Venafaxine ----------- ------------ somatic psychic somatic psychic HARS scores Baseline 11.2 14.3 11.4 14.5 Change from baseline at 8 weeks -41% -36% -49% sup(a) -50% sup(a) Change from baseline at 6 months -43% -34% -58% sup(a) -57% sup(a) Respondents (patients) 8 weeks 43% 38% 56% sup(a) 58% sup(a) 6 months 47% 35% 67% sup(a) 66% sup(a) --------------------------------------------------------------------- Response = >= 50% improvement in HARS factor score from baseline. a p < 0.001 vs placebo. Latest Change 20001019 Indication Generalised-anxiety-disorders Therapeutic Area Anxiety Disorders Disease Index Disease Treated: Generalised-anxiety-disorders Reference Hackett D, Meoni P, White C, Rasmussen J. Somatic and psychic symptoms of GAD: efficacy of short and long-term venlafaxine XR treatment. International Journal of Neuropsychopharmacology 3 (Suppl. 1): 282-283 (plus poster), Jul 2000 Wyeth Ayerst Research, Paris, France. Update Code
20020603 *Copyright Adis International 2002* Sample 2 Accession Number 800845365 Document Type study Adis Title Interferon-alpha + ribavirin: therapeutic use Hepatitis C In HIV-positive patients Adis Comment This study was published as an abstract in the proceedings of the Fifth International Congress on Drug Therapy in HIV infections, held in Glasgow, Scotland in October 2000. Study Messages Efficacy: Interferon-alpha+ ribavirin was reasonably effective in patients with hepatitis C co-infected with HIV. Tolerability: Inteferon-alpha + ribavirin may cause various adverse events including anaemia, depression and pancreatitis in HIV-positive patients with hepatitis C, leading to a high treatment withdrawal rate. Clinical Relevance B Adis Assessment Score Type: efficacy Subjects Type: patients Number: 24 Age: not stated Co-morbid conditions: HIV-infections Concomitant Medication antiretrovirals (n = 14) Study Purpose This study investigated the efficacy and tolerability interferon-alpha in combination with ribavirin in HIV-positive patients with hepatitis C infections. Author Comments 'After 12 weeks of treatment with interferon and ribavirin 50% of treated patients have become HCV-RNA negative. Drop-out rate due to adverse events is high with 25% during the first 8 weeks. HIV-RNA was not adversely affected, indicating that the concomitant use of ribavirin and antiretroviral treatment may be safe.' Study Details Design: prospective Control: baseline comparison Phase: Phase II Country: not stated End Points: CD4+-cell-count, Viral-load, Virological-response, Laboratory-parameters, Microbiological-response, Response Treatments Treatment Group: Interferon-alpha + ribavirin Group Description: Patients received ribavirin for 2 weeks prior to interferon-alpha initiation. Treatment: Interferon-alpha Treatment Description: Patients received interferon-alpha daily for up to 12 weeks and then weekly for up to 48 weeks. Dose: 5 MU/day Route: not stated Frequency: od Duration: = 12 weeks Status: launched Treatment: Interferon-alpha Treatment Description: Patients received interferon-alpha daily for up to 12 weeks and then weekly for up to 48 weeks. Dose: 15 MU/week Route: not stated Frequency: od Duration: = 48 weeks Status: launched Treatment: Ribavirin Treatment Description: Patients received ribavirin alone for 2 weeks and then in combination with interferon-alpha for up to 60 weeks. Dose: 1200 mg/day Route: PO Frequency: od Duration: = 62 weeks Status: launched Results Highlights Efficacy: Plasma levels of hepatitis C viral RNA became undetectable and elevated liver transaminases normalised in 50% of HIV-infected patients with hepatitis C during treatment with interferon-alpha + ribavirin. Tolerability: 25% of interferon-alpha + ribavirin recipients discontinued treatment because of various toxicities, including anaemia, depression and pancreatitis. Results Text Plasma levels of hepatitis C viral RNA became undetectable and elevated liver transaminases normalised in 50% of patients. Results Table ------------------------------------------- ------------------- Interferon-alpha + ribavirin (n = 24) ---------------------------------------------- baseline 3 months --------------------------------------------------------------- CD4+ cell count (cells/microl) 520 428 HIV viral load (copies/ml) 10 097 1274 HCV RNA-negative (patients) 50% ---------------------------------------------------------------- a p <= 0.05 vs baseline. Adverse Events Text: 25% of patients withdrew due to adverse events including anaemia, depression and pancreatitis during the first 8 weeks of the study. Latest Change 20001123 Indication Hepatitis-C, HIV-1-infections Therapeutic Area Antivirals Disease Index Disease Treated: Hepatitis-C Reference Rockstroh JK, Klausen G, Golz J, Dupke S, Stein L, et al. Interferon-alpha and ribavirin combination therapy for hepatitis C in HIV- coinfected patients. AIDS 14 (Suppl. 4): 123, Oct 2000 University of Bonn, Germany Update Code 20020603
Field Guide Revised May 31, 2005
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