Trial Outcomes & Findings for Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders (NCT NCT02425904)
NCT ID: NCT02425904
Last Updated: 2025-09-26
Results Overview
The OR was defined as the proportion of participants achieving certain response on treatment among LCH patients, criteria were defined per protocol. Better response were defined as achieving complete disease resolution (NAD) or disease regression (AD better); intermediate response defined as stable or unchanged disease status; worse response defined as disease progression.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration has a median of 5.8 months with range 2.1-7 months.
Results posted on
2025-09-26
Participant Flow
from 5/21/2015 to 1/14/2020
Participant milestones
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
5
|
|
Overall Study
Efficacy Analysis
|
20
|
4
|
|
Overall Study
COMPLETED
|
17
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
3
|
Baseline Characteristics
Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
Baseline characteristics by cohort
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
n=5 Participants
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
3.4 years
n=5 Participants
|
38.6 years
n=7 Participants
|
4.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration has a median of 5.8 months with range 2.1-7 months.The OR was defined as the proportion of participants achieving certain response on treatment among LCH patients, criteria were defined per protocol. Better response were defined as achieving complete disease resolution (NAD) or disease regression (AD better); intermediate response defined as stable or unchanged disease status; worse response defined as disease progression.
Outcome measures
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
Response Rate (OR) of LCH Cohort
Better
|
0.85 proportion of participants
Interval 0.62 to 0.97
|
—
|
|
Response Rate (OR) of LCH Cohort
Intermediate
|
0.15 proportion of participants
Interval 0.03 to 0.38
|
—
|
|
Response Rate (OR) of LCH Cohort
Worse
|
0 proportion of participants
Interval 0.0 to 0.0
|
—
|
PRIMARY outcome
Timeframe: Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. Treatment duration has a median of 5.5 months with range 1.7-5.6 months.Population: 1 patient excluded because of problematic enrollment
The OR was defined as the proportion of participants achieving certain response on treatment among LCH-related disorder patients, criteria were defined per protocol. A clinical response of progressive metabolic disease (PMD) defined as CT-based target lesion abnormal and bone marrow new or recurrent involvement; partial metabolic response (PMR) defined as CT-based target lesion decreasing or disease regressed.
Outcome measures
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=4 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
Response Rate of LCH-related Disorders Cohort
PMR
|
0.75 proportion of participants
Interval 0.19 to 0.99
|
—
|
|
Response Rate of LCH-related Disorders Cohort
PMD
|
0.26 proportion of participants
Interval 0.006 to 0.81
|
—
|
SECONDARY outcome
Timeframe: At 1 year1-year PFS defined as the proportion of patients that survival progression free at 1 year. PFS based on the duration of time from study entry to documented disease progression (PD) or death. Per protocol criteria: where time to event for PFS is the time from study enrollment until the time of first occurrence of new lesions, progressive disease, or death from any cause, or until last contact if no event occurs.
Outcome measures
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
n=4 Participants
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
1-year Progression Free Survival (PFS)
|
0.89 proportion of patients
|
0.5 proportion of patients
|
SECONDARY outcome
Timeframe: At 1 year1-year OS defined as the proportion of patients that survival at 1 year. OS calculated as the time from enrollment until death or censored at date last known alive.
Outcome measures
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
n=4 Participants
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
1-year Overall Survival (OS)
|
1 proportion of patients
|
0.75 proportion of patients
|
SECONDARY outcome
Timeframe: Disease was evaluated at baseline and the end of cycle 2. Treatment continued after cycle 2 until disease progression or unacceptable toxicity. LCH treatment duration is median 5.8 with range 2.1-7 months; LCH-related treatment duration is 5.5 (1.7-5.6).All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.0 as reported on case report forms were counted. Number of Participants with at least one Grade 3 or Higher Treatment-Related Toxicity defined as number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Outcome measures
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 Participants
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
LCH-related Disorders + Clofarabine
n=4 Participants
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
|
|---|---|---|
|
Number of Participants With at Least One Grade 3 or Higher Treatment-Related Toxicity
|
15 Participants
|
4 Participants
|
Adverse Events
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
Serious events: 15 serious events
Other events: 20 other events
Deaths: 0 deaths
LCH-related Disorders + Clofarabine
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 participants at risk
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
Clofarabine: second-generation purine nucleoside analog
|
LCH-related Disorders + Clofarabine
n=4 participants at risk
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
Clofarabine: second-generation purine nucleoside analog
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
8/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
100.0%
4/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Device related infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
30.0%
6/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Lung infection
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphocyte count decreased
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Mucosal infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
40.0%
8/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
100.0%
4/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Recurrent or Refractory Langerhans Cell Histiocytosis (LCH) + Clofarabine
n=20 participants at risk
Participants with recurrent or refractory LCH defined as with multi-focal or multi-system disease who have recurred (or have refractory disease) after at least one prior systemic chemotherapy regimen.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
Clofarabine: second-generation purine nucleoside analog
|
LCH-related Disorders + Clofarabine
n=4 participants at risk
Participants with LCH-related disorders defined as who require systemic chemotherapy including participants with Rosai Dorfman Disease (RDD) who have not responded to or recurred after treatment with corticosteroids. Erdheim Chester Disease (ECD) subjects who have confirmed presence of BRAF V600E mutation must have not responded to, have recurred after, or be unable to receive treatment with a BRAF inhibitor.
Patient will receive Clofarabine administered via IV on days 1-5, 25 mg/m2/day per cycle for 2 cycles. At the end of cycle 2 if no disease progression, will continue with same dose for maintenance treatment for 4 additional cycles.
Clofarabine: second-generation purine nucleoside analog
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Allergic reaction
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Anal pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
5/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Ataxia
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Confusion
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
55.0%
11/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
8/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema face
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema trunk
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Eye infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
45.0%
9/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
75.0%
3/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
50.0%
10/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hypothyroidism
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Irritability
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Lip infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Lip pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Localized edema
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
55.0%
11/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
75.0%
3/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Obesity
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Otitis media
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
4/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Palpitations
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.0%
7/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectal pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Scleral disorder
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Sinus tachycardia
|
35.0%
7/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary tract pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Vaginal pain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
12/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
50.0%
2/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight gain
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
5.0%
1/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
25.0%
1/4 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
—
0/0 • Adverse events are assessed every cycle until the end of treatment. LCH Cohort treatment duration has a median of 5.8 months with range 2.1-7 months. LCH-related Disorders Cohort Treatment duration has a median of 5.5 months with range 1.7-5.6 months.
Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Barbara Degar, MD
Dana-Farber Cancer Institute/Boston Children's Hospital
Phone: 617-632-5186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place