NCT04999085 · 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
- Up to 3 months. The protocol does not require adverse event assessment.
- Other-event reporting threshold
- 0%
The protocol does not require adverse event assessment. Adverse Event Data was not collected.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Supportive Care | 0 / 0 | 0 / 0 | 1 / 16 |
Serious adverse events
Other reported adverse events
Complete source fields
- description
- The protocol does not require adverse event assessment. Adverse Event Data was not collected.
- event Groups
- deaths Num Affected
- 1
- deaths Num At Risk
- 16
- description
- Supportive care interventions: Subjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria).
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Supportive Care
- frequency Threshold
- 0
- time Frame
- Up to 3 months. The protocol does not require adverse event assessment.
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Preserved source evidence · Not medical advice
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