Isofol´s Glossary
The following explanations are helpful in understanding certain specific terms and expressions that Isofol uses:
| Censoring in the AGENT study | PFS data for all patient in the study cannot be included in the analysis due to that they have started another treatment prior to reaching progress. The exclusion is done according to FDA and EMA guidelines, which were in force at the start of the study. |
| CMC | Chemistry, manufacturing and controls |
| CRC | Colorectal cancer |
| iDSMB | Independent Data Safety Monitoring Board |
| EMA | European Medicines Agency |
| FDA | US Food and Drug Administration |
| Final study result | More detailed information from the study is planned for presentation at medical congresses and/or in peer-reviewed journals. |
| IND | Investigational New Drug (for the FDA) |
| Interim analysis | The AGENT study included an interim analysis, the primary objective of which was to finalize the size of the study, meaning how many patients are to be enrolled |
| [6R]-MTHF | [6R]-5,10-methylenetetrahydrofolate |
| MTX | Methotrexate |
| NDA | New Drug Application |
| ORR | Objective response rate |
| OS | Overall survival |
| PFS | Progression Free Survival |
| PMDA | Japanese Pharmaceuticals and Medical Devices Agency |
| SAP | Statistical Analysis Plan |
| TGA | Australian Therapeutic Goods Administration |
| Top-line result | A summary from a clinical study of demographic data, data for the primary endpoint and a summary of safety data, which is based on a deblinded, locked database. |
Study phases
Preclinical study
Research that takes place before a drug or treatment method is sufficiently documented to be studied in humans. Includes testing of substances on tissue samples and subsequent testing on laboratory animals.
Clinical study/trial
Investigation of a new drug or treatment method on healthy volunteers or patients where the aim is to study the efficacy and safety of an as yet unapproved form of treatment.
Clinical phase l
The first time when a new substance is given to humans. Phase I studies are often carried out on a small number of healthy volunteers to study safety and dosage for an as yet unapproved form of treatment.
Clinical phase ll
Phase ll refers to the first time when a drug under development is given to patients to study the safety, dosage and efficacy of an as yet unapproved form of treatment.
Clinical phase lll
Phase lll studies/trials comprise numerous patients and are often conducted over an extended period of time. They are intended to map the efficacy and side effects of the drug under ordinary but still closely monitored conditions.
Pivotal study
A clinical study designed to provide data on the efficacy and safety of the drug when applying for market approval from the FDA or EMA, for example.
Phase IV study
A Phase IV study, also referred to as a postmarketing surveillance trial or drug surveillance, is intended to ensure the drug’s long-term safety and efficacy.
Last updated 12-07-2022
