NCT02619682 · 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
- Median 4.6 years from start of therapy
- Other-event reporting threshold
- 3.3%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Post Autologous Transplant Maintenance | 4 / 30 | 30 / 30 | 9 / 30 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- pneumonia with sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- Pneumonia without sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- RSV Upper respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- palpitations
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 30
- term
- hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- term
- hypoglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 30
- term
- lymphocyte decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 30
- term
- lymphocyte decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 30
- term
- phosphorus decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 30
- term
- upper respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 30
- term
- WBC decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 30
- term
- WBC decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 4
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 30
- term
- ANC decreased
Complete source fields
- event Groups
- deaths Num Affected
- 9
- deaths Num At Risk
- 30
- description
- one arm = all enrolled MM patients got post autologous transplant maintenance therapy
- id
- EG000
- other Num Affected
- 30
- other Num At Risk
- 30
- serious Num Affected
- 4
- serious Num At Risk
- 30
- title
- Post Autologous Transplant Maintenance
- frequency Threshold
- 3.3
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 30
- term
- hyperglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- term
- hypoglycemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 30
- term
- lymphocyte decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 30
- term
- lymphocyte decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 30
- term
- phosphorus decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 30
- term
- upper respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 30
- term
- WBC decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 30
- term
- WBC decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 3
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 4
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- term
- Platelet decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- grade 2
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 30
- term
- ANC decreased
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- pneumonia with sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- Pneumonia without sepsis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- RSV Upper respiratory tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- hospitalization
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- term
- palpitations
- time Frame
- Median 4.6 years from start of therapy
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle