NCT00392834 · 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
- Not reported
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Regimen A (R-CODOX-M Chemotherapy) | 0 / 2 | 0 / 2 | Not reported / Not reported |
| Regimen B (Rituximab and IVAC Chemotherapy) | 23 / 32 | 22 / 32 | Not reported / Not reported |
Serious adverse events
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 7
- term
- Anemia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 32
- num Events
- 8
- term
- Febrile neutropenia
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Acute coronary syndrome
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Left ventricular systolic dysfunction
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- supraventricular tachycardia
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Extraocular muscle paresis
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Nausea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Vomiting
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Death NOS
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Fever
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Catheter related infection
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 5
- term
- Infections and infestations, other
Other reported adverse events
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 32
- num Events
- 34
- term
- Anemia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 4
- term
- Febrile neutropenia
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 3
- term
- Diarrhea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Oral mucositis
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 4
- term
- Nausea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 32
- num Events
- 7
- term
- Vomiting
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 3
- term
- Pain
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Urinary tract infection
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Activated partial thromboplastin time prolonged
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 9
- term
- Alanine aminotransferase increased
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 32
- num Events
- 14
- term
- Aspartate aminotransferase increased
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 6
- term
- Blood bilirubin increased
Complete source fields
- event Groups
- description
- Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
- id
- EG000
- other Num Affected
- 0
- other Num At Risk
- 2
- serious Num Affected
- 0
- serious Num At Risk
- 2
- title
- Regimen A (R-CODOX-M Chemotherapy)
- description
- Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
- id
- EG001
- other Num Affected
- 22
- other Num At Risk
- 32
- serious Num Affected
- 23
- serious Num At Risk
- 32
- title
- Regimen B (Rituximab and IVAC Chemotherapy)
- frequency Threshold
- 5
- other Events
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 32
- num Events
- 34
- term
- Anemia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 4
- term
- Febrile neutropenia
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 3
- term
- Diarrhea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Oral mucositis
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 4
- term
- Nausea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 32
- num Events
- 7
- term
- Vomiting
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 3
- term
- Pain
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Urinary tract infection
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Activated partial thromboplastin time prolonged
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 9
- term
- Alanine aminotransferase increased
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 32
- num Events
- 14
- term
- Aspartate aminotransferase increased
- organ System
- Investigations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 32
- num Events
- 6
- term
- Blood bilirubin increased
- serious Events
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 10
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 7
- term
- Anemia
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 32
- num Events
- 8
- term
- Febrile neutropenia
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Acute coronary syndrome
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Left ventricular systolic dysfunction
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- supraventricular tachycardia
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Extraocular muscle paresis
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Nausea
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Vomiting
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 32
- num Events
- 2
- term
- Death NOS
- organ System
- General disorders
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Fever
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 32
- num Events
- 1
- term
- Catheter related infection
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA (10.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 2
- num Events
- 0
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 32
- num Events
- 5
- term
- Infections and infestations, other
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Preserved source evidence · Not medical advice
Triangle