Completion of clinical trial
Item
1. the subject completed 24 weeks of trial 27918.
boolean
C2732579 (UMLS CUI [1])
Clinical Trials; Requirement; Complete
Item
2. the subject successfully completed all trial requirements in trial 27918.
boolean
C0008976 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Postmenopausal state; Duration (temporal concept) | Female Sterilization | Hysterectomy | Contraceptive methods | Childbearing Potential
Item
3. if female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. for the purposes of this trial, women of childbearing potential are defined as: "all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive".
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C1960468 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0429595 (UMLS CUI [5,2])
C0232970 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C0021359 (UMLS CUI [5,5])
C0241028 (UMLS CUI [5,6])
Informed Consent
Item
4. subject is willing and able to participate in the trial and has provided written, informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
1. if female, the subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adverse event; Significant; Time | Risk | Clinical Investigators; Opinions
Item
2. the subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
boolean
C0877248 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2])
C0008961 (UMLS CUI [3,1])
C0871010 (UMLS CUI [3,2])
Deterioration of status; Significant; Time
Item
3. the subject has shown clinically significant deterioration during participation in trial 27918.
boolean
C1279889 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Motor deterioration; Time | Antiparkinson Agents; Titration Method
Item
4. motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
boolean
C1866284 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0162621 (UMLS CUI [2,2])
Conflict of Interest
Item
5. the investigator deems it is not in the subject's best interest to participate to trial 27938
boolean
C0079152 (UMLS CUI [1])
Transmissible spongiform encephalopathy | Brain; Signs and Symptoms; Suggestive of Unit
Item
6. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
boolean
C3700367 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])