TriangleNCT01920932 · OUTCOME
Descriptive of Hematological Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From enrollment to end of therapy (approximately 8 months)
What was measured
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Analysis population: Toxicities reported below for the current study (HLHR13) include all reported hematological toxicities from a participant's on-study date through end of therapy.
Groups in this outcome
Cycle 1 - Grade 2
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
Cycle 1 - Grade 3-4
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
Cycle 2 - Grade 2
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
Cycle 2 - Grade 3-4
Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
Cycle 3 - Grade 2
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 3 - Grade 3-4
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 4 - Grade 2
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 4 - Grade 3-4
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 5 - Grade 2
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 5 - Grade 3-4
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 6 - Grade 2
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
Cycle 6 - Grade 3-4
Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
| Group | Source count |
|---|---|
| Cycle 1 - Grade 2 | 77 |
| Cycle 1 - Grade 3-4 | 77 |
| Cycle 2 - Grade 2 | 77 |
| Cycle 2 - Grade 3-4 | 77 |
| Cycle 3 - Grade 2 | 77 |
| Cycle 3 - Grade 3-4 | 77 |
| Cycle 4 - Grade 2 | 76 |
| Cycle 4 - Grade 3-4 | 76 |
| Cycle 5 - Grade 2 | 76 |
| Cycle 5 - Grade 3-4 | 76 |
| Cycle 6 - Grade 2 | 76 |
| Cycle 6 - Grade 3-4 | 76 |
Reported measurements
Leukopenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1 - Grade 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cycle 1 - Grade 3-4 | 49 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 2 | 28 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 3-4 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 3-4 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 3-4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 3-4 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 2 | 14 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 3-4 | 5 | Not reported | Not reported | Not reported | Not reported |
Neutropenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1 - Grade 2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cycle 1 - Grade 3-4 | 62 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 3-4 | 51 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 3-4 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 3-4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 3-4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 3-4 | 6 | Not reported | Not reported | Not reported | Not reported |
Lymphopenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1 - Grade 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cycle 1 - Grade 3-4 | 36 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 2 | 18 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 3-4 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 3-4 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 2 | 16 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 3-4 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 3-4 | 22 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 2 | 20 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 3-4 | 31 | Not reported | Not reported | Not reported | Not reported |
Anemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1 - Grade 2 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cycle 1 - Grade 3-4 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 2 | 28 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 3-4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 3-4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
Thrombocytopenia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cycle 1 - Grade 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cycle 1 - Grade 3-4 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cycle 2 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cycle 3 - Grade 3-4 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cycle 4 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cycle 5 - Grade 3-4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cycle 6 - Grade 3-4 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 23
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 14
- group Id
- OG011
- value
- 5
- title
- Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 62
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 51
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 6
- title
- Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 13
- group Id
- OG009
- value
- 22
- group Id
- OG010
- value
- 20
- group Id
- OG011
- value
- 31
- title
- Lymphopenia
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 1
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 2
- title
- Thrombocytopenia
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 77
- group Id
- OG003
- value
- 77
- group Id
- OG004
- value
- 77
- group Id
- OG005
- value
- 77
- group Id
- OG006
- value
- 76
- group Id
- OG007
- value
- 76
- group Id
- OG008
- value
- 76
- group Id
- OG009
- value
- 76
- group Id
- OG010
- value
- 76
- group Id
- OG011
- value
- 76
- units
- Participants
- description
- To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- groups
- description
- Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
- id
- OG000
- title
- Cycle 1 - Grade 2
- description
- Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
- id
- OG001
- title
- Cycle 1 - Grade 3-4
- description
- Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
- id
- OG002
- title
- Cycle 2 - Grade 2
- description
- Participants receive AEPA regimen for 2 cycles (cycle length 28 days) (A) Brentuximab vedotin 1.2 mg/kg IV (E) Etoposide 125 mg/m\^2 IV (P) Prednisone 60 mg/m\^2/day PO (orally) (A) Doxorubicin 40 mg/m\^2 IV For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given.
- id
- OG003
- title
- Cycle 2 - Grade 3-4
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG004
- title
- Cycle 3 - Grade 2
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG005
- title
- Cycle 3 - Grade 3-4
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG006
- title
- Cycle 4 - Grade 2
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG007
- title
- Cycle 4 - Grade 3-4
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG008
- title
- Cycle 5 - Grade 2
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG009
- title
- Cycle 5 - Grade 3-4
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG010
- title
- Cycle 6 - Grade 2
- description
- Participants receive CAPDac regimen for 4 cycles (cycle length 21 days): (C) Cyclophosphamide IV 500 mg/m\^2 (A) Brentuximab vedotin 1.2 mg/kg IV (P) Prednisone 40 mg/40 mg/m\^2/day PO (Dac) Dacarbazine 250 mg/m\^2 IV
- id
- OG011
- title
- Cycle 6 - Grade 3-4
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Toxicities reported below for the current study (HLHR13) include all reported hematological toxicities from a participant's on-study date through end of therapy.
- reporting Status
- POSTED
- time Frame
- From enrollment to end of therapy (approximately 8 months)
- title
- Descriptive of Hematological Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice