NCT01081262 · 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
- Study treatment and up to 5 years after treatment discontinuation
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | 3 / 13 | 13 / 13 | Not reported / Not reported |
| Arm II (Oxaliplatin and Capecitabine) | 4 / 13 | 13 / 13 | Not reported / Not reported |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | 2 / 13 | 13 / 13 | Not reported / Not reported |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | 3 / 11 | 11 / 11 | Not reported / Not reported |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Allergic reaction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Bleeding
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Diarrhea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Dyspnea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Fever
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- GI perforation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Hypomagnesemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Platelets
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Laryngeal Spasm
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Lymphocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Low Mood
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Low Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Low platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 11
- term
- Low White Blood Cells
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 11
- term
- Mucositis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 11
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 11
- term
- Oral problems
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Other GI Problems
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Pain
Complete source fields
- event Groups
- description
- Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- EG000
- other Num Affected
- 13
- other Num At Risk
- 13
- serious Num Affected
- 3
- serious Num At Risk
- 13
- title
- Arm I (Carboplatin and Paclitaxel)
- description
- Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- EG001
- other Num Affected
- 13
- other Num At Risk
- 13
- serious Num Affected
- 4
- serious Num At Risk
- 13
- title
- Arm II (Oxaliplatin and Capecitabine)
- description
- Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- EG002
- other Num Affected
- 13
- other Num At Risk
- 13
- serious Num Affected
- 2
- serious Num At Risk
- 13
- title
- Arm III (Carboplatin, Paclitaxel, Bevacizumab)
- description
- Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. Bevacizumab: Given IV Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Oxaliplatin: Given IV Quality-of-Life Assessment: Ancillary studies
- id
- EG003
- other Num Affected
- 11
- other Num At Risk
- 11
- serious Num Affected
- 3
- serious Num At Risk
- 11
- title
- Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Laryngeal Spasm
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Lymphocytes
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Low Mood
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Low Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Low platelets
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 11
- term
- Low White Blood Cells
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 11
- term
- Mucositis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 11
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 11
- term
- Oral problems
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Other
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Other GI Problems
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 11
- term
- Pain
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Allergic reaction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Bleeding
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- Diarrhea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Dyspnea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Fever
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 11
- term
- GI perforation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Hypomagnesemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Neutrophils
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE (4.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 13
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 13
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 11
- term
- Low Platelets
- time Frame
- Study treatment and up to 5 years after treatment discontinuation
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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