Trial Outcomes & Findings for Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC (NCT NCT00997334)
NCT ID: NCT00997334
Last Updated: 2018-02-23
Results Overview
Participants were classified into 4 potential resistant mechanism groups (4 genetic/ 1 histologic) based on evaluation of rebiopsy tissue: EGFR mutations (T790M mutation, exon 20 insertion), KRAS mutations, MET amplification or small-cell lung cancer (SCLC) transform using established methods.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort.
Results posted on
2018-02-23
Participant Flow
Study activated December 2009. Patients enrolled from February 2010 - January 2015
Participant milestones
| Measure |
Erlotinib
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Eligible for Repeat Biopsy
|
44
|
|
Overall Study
Evaluable
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Erlotinib
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Overall Study
still on therapy
|
12
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Patient non-compliance
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Urgent Palliative Care
|
2
|
|
Overall Study
No lesion amenable
|
1
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC
Baseline characteristics by cohort
| Measure |
Erlotinib
n=60 Participants
Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=99 Participants
|
|
Smoking Status
Never-Smoker
|
34 Participants
n=99 Participants
|
|
Smoking Status
Smoker
|
26 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort.Population: The analysis dataset is comprised of all evaluable patients.
Participants were classified into 4 potential resistant mechanism groups (4 genetic/ 1 histologic) based on evaluation of rebiopsy tissue: EGFR mutations (T790M mutation, exon 20 insertion), KRAS mutations, MET amplification or small-cell lung cancer (SCLC) transform using established methods.
Outcome measures
| Measure |
Erlotinib
n=35 Participants
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Resistance Mechanism
MET amplification
|
1 participants
|
|
Resistance Mechanism
T790M mutation
|
23 participants
|
|
Resistance Mechanism
SCLC Transformation
|
3 participants
|
|
Resistance Mechanism
Unknown
|
4 participants
|
|
Resistance Mechanism
Insufficient Tissue
|
4 participants
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.Population: The analysis dataset is comprised of all treated patients.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Erlotinib
n=60 Participants
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Progression-Free Survival
|
11.1 months
Interval 9.1 to 14.8
|
POST_HOC outcome
Timeframe: At time of removal from study, patients were asked to undergo a repeat biopsy of their progressing or new tumor lesion. Progression follow up was up to 3 years in this study cohort.Population: The analysis dataset is comprised of all evaluable patients.
Time to repeat biopsy is the duration of time from clinical determination of progressive disease to time of repeat biopsy.
Outcome measures
| Measure |
Erlotinib
n=35 Participants
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Time to Repeat Biopsy
|
12 days
Interval 0.0 to 97.0
|
POST_HOC outcome
Timeframe: Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.Population: The analysis dataset is comprised of all patients eligible for repeat biopsy.
Feasibility in this study is defined as the percentage of patients who completed a repeated biopsy per protocol after evidence of disease progression.
Outcome measures
| Measure |
Erlotinib
n=44 Participants
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Feasibility Rate
|
79.5 percentage of participants
Interval 67.0 to 88.9
|
Adverse Events
Erlotinib
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=60 participants at risk
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Gastrointestinal disorders
Viral Enteritis
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Abdomen NOS
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Abdomen NOS
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Ulcer, colon
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Cardiac disorders
Cardiac - ischemia
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Cardiac disorders
Cardiac General-Other
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
Other adverse events
| Measure |
Erlotinib
n=60 participants at risk
Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
4/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, conjunctiva
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, eye NOS
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection Gr0-2 neut, ungual
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC conjunctiva
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC mucosa
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC oral cavity/gums
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC ungual (nails)
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
8.3%
5/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Eye disorders
Dry eye syndrome
|
15.0%
9/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Eye disorders
Eyelid dysfunction
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Eye disorders
Ocular surface disease
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Eye disorders
Tearing
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Eye disorders
Ocular-other
|
18.3%
11/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Chelitis
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Constipation
|
11.7%
7/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
81.7%
49/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
5/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
6.7%
4/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) esophagus
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
18/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
GI-other
|
6.7%
4/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Upper GI, hemorrhage NOS
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Abdomen, pain
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Fatigue
|
43.3%
26/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Fever w/o neutropenia
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Rigors/chills
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Edema limb
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Pain-other
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
General disorders
Syndromes-other
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection w/ unk ANC vagina
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Infections and infestations
Infection-other
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Leukocytes
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Neutrophils
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Weight gain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Weight loss
|
15.0%
9/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Alkaline phosphatase
|
8.3%
5/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
ALT, SGPT
|
13.3%
8/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
AST, SGOT
|
25.0%
15/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Bilirubin
|
18.3%
11/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Investigations
Metabolic/Laboratory-other
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
16/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Taste disturbance
|
13.3%
8/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Neuropathy CN IX pharynx ear tongue
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Neuropathy CN XII tongue
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Head/headache
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Nervous system disorders
Neuropathic, pain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
8.3%
5/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
3.3%
2/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
5.0%
3/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.0%
36/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.7%
19/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
21.7%
13/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
20.0%
12/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
70.0%
42/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
31.7%
19/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
35.0%
21/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Skin and subcutaneous tissue disorders
Scalp, pain
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Vascular disorders
Flushing
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
|
Vascular disorders
Vascular-Other (Specify)
|
1.7%
1/60 • Assessed each cycle on treatment up to day 30 post-treatment. Median (range) treatment duration for this study cohort was 10 months (1-62 months).
Serious adverse events (AEs) per protocol are reported. For Other AEs, maximum grade toxicity by type (based on CTCAEv3 which includes coding events as 'Other') for a patient over time including only events with treatment-attribution of possibly, probably or definitely was calculated. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place