NCT03082534 · 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
- 8 years
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort 1 | 19 / 33 | 32 / 33 | 27 / 33 |
| Cohort 2 | 9 / 25 | 25 / 25 | 19 / 25 |
| Cohort 3 | 6 / 10 | 10 / 10 | 9 / 10 |
| Cohort 4 | 5 / 10 | 10 / 10 | 8 / 10 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Atrial flutter
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Electrocardiogram QT corrected interval prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Colitis
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 33
- num Events
- 9
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 25
- num Events
- 19
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 10
- num Events
- 5
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 2
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- num Events
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Hearing impairment
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 33
- num Events
- 5
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 6
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Floaters
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- num Events
- 5
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Cheilitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 33
- num Events
- 9
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 33
- num Events
- 16
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 5
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 10
- num Events
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 2
- term
- Diarrhea
Complete source fields
- event Groups
- deaths Num Affected
- 27
- deaths Num At Risk
- 33
- description
- PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
- id
- EG000
- other Num Affected
- 32
- other Num At Risk
- 33
- serious Num Affected
- 19
- serious Num At Risk
- 33
- title
- Cohort 1
- deaths Num Affected
- 19
- deaths Num At Risk
- 25
- description
- PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
- id
- EG001
- other Num Affected
- 25
- other Num At Risk
- 25
- serious Num Affected
- 9
- serious Num At Risk
- 25
- title
- Cohort 2
- deaths Num Affected
- 9
- deaths Num At Risk
- 10
- description
- PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
- id
- EG002
- other Num Affected
- 10
- other Num At Risk
- 10
- serious Num Affected
- 6
- serious Num At Risk
- 10
- title
- Cohort 3
- deaths Num Affected
- 8
- deaths Num At Risk
- 10
- description
- cutaneous HNSCC Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
- id
- EG003
- other Num Affected
- 10
- other Num At Risk
- 10
- serious Num Affected
- 5
- serious Num At Risk
- 10
- title
- Cohort 4
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 33
- num Events
- 9
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 25
- num Events
- 19
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 10
- num Events
- 5
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 2
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- num Events
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Hearing impairment
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Hyperthyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 33
- num Events
- 5
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 4
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 6
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Floaters
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- num Events
- 5
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Cheilitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 33
- num Events
- 9
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 33
- num Events
- 16
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 25
- num Events
- 5
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 10
- num Events
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 2
- term
- Diarrhea
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 25
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Atrial flutter
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Electrocardiogram QT corrected interval prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 25
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Heart failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 33
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- term
- Myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 25
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- term
- Colitis
- time Frame
- 8 years
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
Triangle