NCT04459416 · 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
- 90 days
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Acupuncture Plus Usual Care | 0 / 151 | 39 / 151 | 0 / 151 |
| Usual Care | 0 / 147 | 0 / 147 | 0 / 147 |
Serious adverse events
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Bruising
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Burning sensation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Skin discoloration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Foot cramping
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Nose bleed
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Pain/Soreness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Throbbing sensation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Tiredness
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 151
- description
- Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
- id
- EG000
- other Num Affected
- 39
- other Num At Risk
- 151
- serious Num Affected
- 0
- serious Num At Risk
- 151
- title
- Acupuncture Plus Usual Care
- deaths Num Affected
- 0
- deaths Num At Risk
- 147
- description
- Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 147
- serious Num Affected
- 0
- serious Num At Risk
- 147
- title
- Usual Care
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Bruising
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Burning sensation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Skin discoloration
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Foot cramping
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Nose bleed
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Pain/Soreness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Throbbing sensation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 151
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 147
- term
- Tiredness
- time Frame
- 90 days
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