NCT02362997 · 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
- Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | 8 / 31 | 29 / 31 | 2 / 31 |
| Classical Hodgkin Lymphoma | 3 / 30 | 30 / 30 | 0 / 30 |
| Peripheral T Cell Lymphoma | 1 / 21 | 21 / 21 | 3 / 21 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 31
- num Events
- 6
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 30
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 31
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Enterocolitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right neck mass
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Musculoskeletal and connective tissue disorder - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Squamous cell carcinoma
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Respiratory failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Airway compromise
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Respiratory, thoracic and mediastinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Syncope
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 31
- num Events
- 24
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 30
- num Events
- 17
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 21
- num Events
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 31
- num Events
- 32
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 30
- num Events
- 29
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 21
- num Events
- 22
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 31
- num Events
- 37
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 21
- num Events
- 13
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 31
- num Events
- 23
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 11
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 21
- num Events
- 18
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 30
- num Events
- 12
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 21
- num Events
- 12
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 14
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 30
- num Events
- 13
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 21
- num Events
- 7
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 31
- num Events
- 25
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 9
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 7
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 4
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 12
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 23
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 10
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 11
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 30
- num Events
- 13
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 8
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 24
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 6
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 31
- num Events
- 15
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 30
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Upper respiratory infection
Complete source fields
- event Groups
- deaths Num Affected
- 2
- deaths Num At Risk
- 31
- description
- Pembrolizumab 200mg IV every 3 weeks up to 8 cycles Pembrolizumab: Anti-PD-1 monoclonal antibody
- id
- EG000
- other Num Affected
- 29
- other Num At Risk
- 31
- serious Num Affected
- 8
- serious Num At Risk
- 31
- title
- Diffuse Large B Cell Lymphoma
- deaths Num Affected
- 0
- deaths Num At Risk
- 30
- description
- Pembrolizumab 200mg IV every 3 weeks up to 8 cycles Pembrolizumab: Anti-PD-1 monoclonal antibody
- id
- EG001
- other Num Affected
- 30
- other Num At Risk
- 30
- serious Num Affected
- 3
- serious Num At Risk
- 30
- title
- Classical Hodgkin Lymphoma
- deaths Num Affected
- 3
- deaths Num At Risk
- 21
- description
- Pembrolizumab 200mg IV every 3 weeks up to 8 cycles Pembrolizumab: Anti-PD-1 monoclonal antibody
- id
- EG002
- other Num Affected
- 21
- other Num At Risk
- 21
- serious Num Affected
- 1
- serious Num At Risk
- 21
- title
- Peripheral T Cell Lymphoma
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 31
- num Events
- 24
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 30
- num Events
- 17
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 21
- num Events
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 31
- num Events
- 32
- group Id
- EG001
- num Affected
- 14
- num At Risk
- 30
- num Events
- 29
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 21
- num Events
- 22
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 31
- num Events
- 37
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 18
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 21
- num Events
- 13
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 31
- num Events
- 23
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 11
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 21
- num Events
- 18
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 30
- num Events
- 12
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 21
- num Events
- 12
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 14
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 30
- num Events
- 13
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 21
- num Events
- 7
- term
- Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 31
- num Events
- 25
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 9
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 2
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 30
- num Events
- 7
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 21
- num Events
- 4
- term
- Dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 12
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 23
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 10
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 31
- num Events
- 11
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 30
- num Events
- 13
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 21
- num Events
- 8
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 31
- num Events
- 19
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 30
- num Events
- 24
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 21
- num Events
- 6
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 31
- num Events
- 15
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 30
- num Events
- 14
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Upper respiratory infection
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 31
- num Events
- 6
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 30
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 31
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Enterocolitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 30
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right neck mass
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Musculoskeletal and connective tissue disorder - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Squamous cell carcinoma
- organ System
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 31
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 21
- num Events
- 1
- term
- Respiratory failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Airway compromise
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Respiratory, thoracic and mediastinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 31
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 30
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 21
- num Events
- 0
- term
- Syncope
- time Frame
- Safety assessments will be performed on day 1 of each of up to 8 treatment cycles (28-day cycle) followed by assessments every 3 months until up to 18-months post-ASCT
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Preserved source evidence · Not medical advice
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