Trial Outcomes & Findings for Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma (NCT NCT03046953)
NCT ID: NCT03046953
Last Updated: 2024-07-16
Results Overview
Best overall response rate (Completed response \[CR\] + partial remission \[PR\]) during the first 8 cycles of treatment will be assessed using contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma. In this study CR = complete disappearance of all detectable clinical evidence of disease, so involved lymph nodes had regressed on CT scan to normal size. PR = al least a 50% decrease in size of the involved lymph nodes measured on CT scans.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
8 cycles (224 days)
Results posted on
2024-07-16
Participant Flow
Patient were recruited from November 14, 2017 to November 18, 2019 at 14 UK (United Kingdom) hospitals by clinician referral. The first patient was recruited on December 8, 2017, and the final patient recruited on November 18, 2019.
Of 35 enrolled patients, only 32 started treatment. Of the 3 patients who did not start treatment, one died, one relapsed and one was found to be ineligible post registration.
Participant milestones
| Measure |
Avelumab
Patients received Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Completed Cycle 3
|
16
|
|
Overall Study
Completed Cycle 6
|
10
|
|
Overall Study
Completed Cycle 8
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Avelumab
Patients received Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Overall Study
Relapse/progressive disease
|
21
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Avelumab
n=35 Participants
Patients received Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 11.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=35 Participants
|
|
Histology
Peripheral T-cell lymphoma not otherwise specified
|
17 Participants
n=35 Participants
|
|
Histology
Angioimmunoblastic T-cell lymphoma
|
11 Participants
n=35 Participants
|
|
Histology
Extranodal NK/T-cell lymphoma
|
4 Participants
n=35 Participants
|
|
Histology
Anaplastic large cell lymphoma
|
1 Participants
n=35 Participants
|
|
Histology
Transformed mycosis fungoides
|
1 Participants
n=35 Participants
|
|
Histology
Missing data
|
1 Participants
n=35 Participants
|
|
Prior therapies
|
3.0 years
n=35 Participants
|
|
ECOG performance
0
|
17 Participants
n=35 Participants
|
|
ECOG performance
1
|
13 Participants
n=35 Participants
|
|
ECOG performance
2
|
4 Participants
n=35 Participants
|
|
ECOG performance
Missing Data
|
1 Participants
n=35 Participants
|
|
Weight
|
81.7 kg
STANDARD_DEVIATION 17.3 • n=34 Participants • 1 patient ineligible post registration
|
|
Height
|
1.7 metres
STANDARD_DEVIATION 0.1 • n=34 Participants • 1 patient was ineligible post registration
|
|
BMI
|
27.0 kg/m2
STANDARD_DEVIATION 5.1 • n=34 Participants • 1 patient was ineligible post registration
|
|
Systolic blood pressure
|
127.0 mmHg
STANDARD_DEVIATION 19.7 • n=34 Participants • 1 patient was ineligible post registration
|
|
Diastolic blood pressure
|
74.2 mmHg
STANDARD_DEVIATION 9.8 • n=34 Participants • 1 patient was ineligible post registration
|
|
Pulse
|
83.7 bpm
STANDARD_DEVIATION 21.7 • n=34 Participants • 1 patient was ineligible post registration
|
PRIMARY outcome
Timeframe: 8 cycles (224 days)Population: The per-protocol population was used ,defined as all patients recruited to the trial who started treatment
Best overall response rate (Completed response \[CR\] + partial remission \[PR\]) during the first 8 cycles of treatment will be assessed using contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma. In this study CR = complete disappearance of all detectable clinical evidence of disease, so involved lymph nodes had regressed on CT scan to normal size. PR = al least a 50% decrease in size of the involved lymph nodes measured on CT scans.
Outcome measures
| Measure |
Avelumab
n=32 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Best Overall Response Rate During the First 8 Cycles of Treatment
|
5 Participants
|
SECONDARY outcome
Timeframe: During treatment of 8 cycles (224 days)Population: The number of patients in the per-protocol population who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
Toxicity assessed using CTCAE v4.0 will be defined as the number of patients who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
Outcome measures
| Measure |
Avelumab
n=32 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Toxicity- Number of Patients
|
21 Participants
|
SECONDARY outcome
Timeframe: During treatment of 8 cycles (224 days)Population: The proportion of patients in the per-protocol population who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
Toxicity assessed using CTCAE v4.0 will be defined as the proportion of patients who experience one or more grade 3 or 4 adverse event or serious adverse event of any grade
Outcome measures
| Measure |
Avelumab
n=32 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Toxicity- Proportion of Patients
|
0.656 proportion of patients
|
SECONDARY outcome
Timeframe: During trial treatment of 8 cycles (224 days), comparing baseline with cycles 3, 6 and 8Population: 13 of the 32 patients who started treatment had available CT scans containing the target lesions at cycles 3, 6 or 8 for comparison with baseline, and these patients were included in this analysis
Maximum percentage change in the sum of the product of diameters (SPD) of target tumour masses assessed by contrast-enhanced CT scans of the neck, chest, abdomen and pelvis, using the Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
Avelumab
n=13 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Maximum Percentage Change in Sum of Product of Diameters
|
-4.3 percentage change
Interval -56.6 to 28.1
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients who responded
Duration of response is defined as the time from first documented response (CR or PR) until relapse/progression, as determined by the Revised Response Criteria, or death. Patients who are relapse/progression free and alive at time of final analysis will be censored at date last seen.
Outcome measures
| Measure |
Avelumab
n=5 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Duration of Response
|
13.3 months
Interval 6.8 to 23.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Per-protocol population defined as all patients recruited to the trial who started treatment
Progression free survival is defined as the time from date of registration to the date of disease progression or date of death from any cause. Patients not reaching progression or death at the time of analysis will be censored at the last date they were known to be alive and progression free.
Outcome measures
| Measure |
Avelumab
n=32 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Progression Free Survival
|
2.86 months
Interval 1.77 to 4.37
|
SECONDARY outcome
Timeframe: Deaths were collected up to 2 yearsPopulation: Per-protocol population
Overall survival time is defined as the time from date of registration to the date of death from any cause. Patients discontinuing the study, lost to follow-up or still alive at the end of the study will be censored at the date of last follow-up.
Outcome measures
| Measure |
Avelumab
n=32 Participants
Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
Avelumab: anti-PDL1 antibody
|
|---|---|
|
Overall Survival
|
10.41 months
Interval 6.6 to 12.25
|
Adverse Events
Avelumab
Serious events: 18 serious events
Other events: 31 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Avelumab
n=32 participants at risk
Avelumab (an anti-PDL1 antibody) 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Eye disorders
Dacrocystitis
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Gastric perforation
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Immune-mediated colitis
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Fever
|
12.5%
4/32 • Number of events 6 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Infusion related reaction
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Edema-groin,scrotum
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Hepatobiliary disorders
Hepatic failure
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Lung/skin infection
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Eye infection
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Fever
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Infection (blood culture positive)
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Lung Infection
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Rhinitis infective
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Sepsis
|
9.4%
3/32 • Number of events 3 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Investigations
Platelet count decreased
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Infections and infestations-Other,specify
|
3.1%
1/32 • Number of events 1 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
Other adverse events
| Measure |
Avelumab
n=32 participants at risk
Avelumab (an anti-PDL1 antibody) 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Constipation
|
15.6%
5/32 • Number of events 5 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
5/32 • Number of events 5 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Mucositis Oral
|
6.2%
2/32 • Number of events 3 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Nausea
|
18.8%
6/32 • Number of events 8 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
5/32 • Number of events 7 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Chills
|
9.4%
3/32 • Number of events 3 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Edema Limbs
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Fatigue
|
25.0%
8/32 • Number of events 12 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Fever
|
25.0%
8/32 • Number of events 11 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Flu Like Symptoms
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Infusion Related Reaction
|
21.9%
7/32 • Number of events 7 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
General disorders
Localised Edema
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Lung infection
|
12.5%
4/32 • Number of events 5 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Sepsis
|
9.4%
3/32 • Number of events 3 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32 • Number of events 4 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Investigations
Alkaline Phosphatase increased
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Investigations
Platelet Count Decreased
|
15.6%
5/32 • Number of events 11 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Investigations
Weight Loss
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
15.6%
5/32 • Number of events 8 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Nervous system disorders
Lethargy
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.1%
9/32 • Number of events 10 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
4/32 • Number of events 4 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • Number of events 2 • Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years.
Safety data for this trial was collected in accordance with CTCAE criteria version 4.0
|
Additional Information
C Morland Cinical Trial Coordinator
CRCTU Birmingham
Phone: +44 121 371 7862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place