NCT03323034 · 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
- Up to 4 years
- Other-event reporting threshold
- 0%
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Part A Dose Level 1: 15 mg/m^2 | 5 / 6 | 6 / 6 | 0 / 6 |
| Part A Dose Level 2: 20 mg/m^2 | 4 / 6 | 6 / 6 | 0 / 6 |
| Part A Dose Level 3: 25 mg/m^2 | 6 / 6 | 6 / 6 | 0 / 6 |
| Part A Dose Level 4: 35 mg/m^2 | 2 / 6 | 6 / 6 | 0 / 6 |
| Part A PK Dose Level 4: 35 mg/m^2 | 4 / 6 | 6 / 6 | 0 / 6 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Ataxia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Bone marrow hypocellular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Flu like symptoms
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Activated partial thromboplastin time prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 6
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Alkaline phosphatase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Allergic rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 6
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Amnesia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Anxiety
Complete source fields
- description
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 5
- serious Num At Risk
- 6
- title
- Part A Dose Level 1: 15 mg/m^2
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG001
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 4
- serious Num At Risk
- 6
- title
- Part A Dose Level 2: 20 mg/m^2
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG002
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 6
- serious Num At Risk
- 6
- title
- Part A Dose Level 3: 25 mg/m^2
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG003
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 2
- serious Num At Risk
- 6
- title
- Part A Dose Level 4: 35 mg/m^2
- deaths Num Affected
- 0
- deaths Num At Risk
- 6
- description
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
- id
- EG004
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 4
- serious Num At Risk
- 6
- title
- Part A PK Dose Level 4: 35 mg/m^2
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Activated partial thromboplastin time prolonged
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 6
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Alkaline phosphatase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Allergic rhinitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 6
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Amnesia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Anxiety
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Anorexia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Ataxia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Blood bilirubin increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Bone marrow hypocellular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Bone pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 6
- term
- Flu like symptoms
- time Frame
- Up to 4 years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle