NCT02728804 · 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
- Duration of study participant - up to 12 months.
- Other-event reporting threshold
- 0%
Serious adverse events and other (non-serious adverse events) were not assessed for the study. All-cause mortality was assessed for the 380 participants at the start of the study.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Health Services Research (Questionnaire Administration) | 0 / 0 | 0 / 0 | 99 / 380 |
Serious adverse events
Other reported adverse events
Complete source fields
- description
- Serious adverse events and other (non-serious adverse events) were not assessed for the study. All-cause mortality was assessed for the 380 participants at the start of the study.
- event Groups
- deaths Num Affected
- 99
- deaths Num At Risk
- 380
- description
- Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months. Quality-of-Life Assessment: Complete questionnaire Questionnaire Administration: Complete questionnaires
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Health Services Research (Questionnaire Administration)
- frequency Threshold
- 0
- time Frame
- Duration of study participant - up to 12 months.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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