NCT00963911 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- at baseline (at completion of the G8 questionnaire)
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Included Patients | 0 / 1674 | 0 / 1674 | 0 / 1674 |
Serious adverse events
Other reported adverse events
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 1674
- description
- Screening tests (G8 and VES-13) The G-8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and selfrated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment. Multidimensional geriatric assessment: Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G).
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 1674
- serious Num Affected
- 0
- serious Num At Risk
- 1674
- title
- Included Patients
- frequency Threshold
- 0
- time Frame
- at baseline (at completion of the G8 questionnaire)
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Preserved source evidence · Not medical advice
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