NCT00966693 · 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
- Baseline to study completion up to 9 years
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| RTD (Cohort 1, Phase 1) | 0 / 3 | 3 / 3 | 0 / 3 |
| RTD (Cohort 2, Phase 1) | 0 / 3 | 3 / 3 | 0 / 3 |
| RTD (Cohort 3, Phase 1) | 1 / 9 | 9 / 9 | 1 / 9 |
| RTD (Cohort 2, Phase 2) | 7 / 49 | 49 / 49 | 0 / 49 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 49
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 49
- term
- Altered Mental Status
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Urinary Tract Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Muscle Weakness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Death
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 49
- term
- Activated PTT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Acidosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Adult Respiratory Distress
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Agitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 16
- num At Risk
- 49
- term
- ALT Increase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 49
- term
- Alkaline Phosphate increase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Allergy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Anal Hemmorhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 49
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 49
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 49
- term
- AST Increase
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- RTD (Cohort 1, Phase 1)
- deaths Num Affected
- 0
- deaths Num At Risk
- 3
- description
- Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
- id
- EG001
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- RTD (Cohort 2, Phase 1)
- deaths Num Affected
- 1
- deaths Num At Risk
- 9
- description
- Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
- id
- EG002
- other Num Affected
- 9
- other Num At Risk
- 9
- serious Num Affected
- 1
- serious Num At Risk
- 9
- title
- RTD (Cohort 3, Phase 1)
- deaths Num Affected
- 0
- deaths Num At Risk
- 49
- description
- Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
- id
- EG003
- other Num Affected
- 49
- other Num At Risk
- 49
- serious Num Affected
- 7
- serious Num At Risk
- 49
- title
- RTD (Cohort 2, Phase 2)
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 49
- term
- Activated PTT
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Acidosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Adult Respiratory Distress
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Agitation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 16
- num At Risk
- 49
- term
- ALT Increase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 49
- term
- Alkaline Phosphate increase
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Allergy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Anal Hemmorhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 49
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 8
- num At Risk
- 49
- term
- Anxiety
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 49
- term
- AST Increase
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 49
- term
- Pneumonia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 49
- term
- Altered Mental Status
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Urinary Tract Infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Muscle Weakness
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 49
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- NCI CTCAE v3.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 49
- term
- Death
- time Frame
- Baseline to study completion up to 9 years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle