NCT02888743 · 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
- Two years
- Other-event reporting threshold
- 5%
SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 9 / 26 | 25 / 26 | 15 / 26 |
| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 11 / 26 | 24 / 26 | 15 / 26 |
| NSCLC Arm C (Tremelimumab, Durvalumab) | 8 / 26 | 24 / 26 | 9 / 26 |
| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 5 / 10 | 9 / 10 | 6 / 10 |
| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 6 / 9 | 9 / 9 | 6 / 9 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Cyanosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Sinus Tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- num Events
- 4
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Diarrhea
Other reported adverse events
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Absolute Neutrophil Count
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 26
- num Events
- 6
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 26
- num Events
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 26
- num Events
- 7
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 10
- num Events
- 5
- group Id
- EG004
- num Affected
- 6
- num At Risk
- 9
- num Events
- 15
- term
- Anemia
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 9
- num Events
- 6
- term
- Decreased Hematocrit
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- num Events
- 3
- term
- Decreased MCHC
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 2
- term
- Decreased RBC
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated Absolute Monocyte
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated Bands
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated BUN
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Eosinophil Count Elevated
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Increased Monocyte Count
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Increased Neutrophils
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Increased Platelets
Complete source fields
- description
- SAEs and non-SAE adverse events reflect all degrees of relatedness to study intervention. Non-SAE events are adverse events that were new or worsening relative to baseline. A 5% threshold was used for reporting non-SAE events (NSCLC: 4 or more of 78, CRC: 1 or more).
- event Groups
- deaths Num Affected
- 15
- deaths Num At Risk
- 26
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- EG000
- other Num Affected
- 25
- other Num At Risk
- 26
- serious Num Affected
- 9
- serious Num At Risk
- 26
- title
- NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
- deaths Num Affected
- 15
- deaths Num At Risk
- 26
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- EG001
- other Num Affected
- 24
- other Num At Risk
- 26
- serious Num Affected
- 11
- serious Num At Risk
- 26
- title
- NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
- deaths Num Affected
- 9
- deaths Num At Risk
- 26
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- EG002
- other Num Affected
- 24
- other Num At Risk
- 26
- serious Num Affected
- 8
- serious Num At Risk
- 26
- title
- NSCLC Arm C (Tremelimumab, Durvalumab)
- deaths Num Affected
- 6
- deaths Num At Risk
- 10
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- EG003
- other Num Affected
- 9
- other Num At Risk
- 10
- serious Num Affected
- 5
- serious Num At Risk
- 10
- title
- CRC Arm A (Tremelimumab, Durvalumab, HD-RT)
- deaths Num Affected
- 6
- deaths Num At Risk
- 9
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- EG004
- other Num Affected
- 9
- other Num At Risk
- 9
- serious Num Affected
- 6
- serious Num At Risk
- 9
- title
- CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
- frequency Threshold
- 5
- other Events
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Absolute Neutrophil Count
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 26
- num Events
- 6
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 26
- num Events
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 26
- num Events
- 7
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 10
- num Events
- 5
- group Id
- EG004
- num Affected
- 6
- num At Risk
- 9
- num Events
- 15
- term
- Anemia
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 9
- num Events
- 6
- term
- Decreased Hematocrit
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- num Events
- 3
- term
- Decreased MCHC
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 2
- term
- Decreased RBC
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated Absolute Monocyte
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 2
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated Bands
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Elevated BUN
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Eosinophil Count Elevated
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Increased Monocyte Count
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Increased Neutrophils
- 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
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Increased Platelets
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Cyanosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Sinus Tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Hypothyroidism
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Adrenal insufficiency
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Blurred vision
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 9
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 9
- num Events
- 4
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 26
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 10
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 26
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 10
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Diarrhea
- time Frame
- Two years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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