Trial Outcomes & Findings for Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer (NCT NCT00216203)
NCT ID: NCT00216203
Last Updated: 2016-09-29
Results Overview
The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
12 months
Results posted on
2016-09-29
Participant Flow
Participant milestones
| Measure |
Pemetrexed + Cetuximab
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cetuximab
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cetuximab
n=33 Participants
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG PS 0
|
19 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG PS 1
|
14 participants
n=93 Participants
|
|
Disease Stage
Disease Stage III
|
2 participants
n=93 Participants
|
|
Disease Stage
Disease Stage IV
|
31 participants
n=93 Participants
|
|
Tumor Histology
Adenocarcinoma
|
18 participants
n=93 Participants
|
|
Tumor Histology
Squamous cell carcinoma
|
8 participants
n=93 Participants
|
|
Tumor Histology
Large cell carcinoma
|
2 participants
n=93 Participants
|
|
Tumor Histology
Non-small cell carcinoma (NOS)
|
5 participants
n=93 Participants
|
|
Smoking History
Current Smoker
|
6 participants
n=93 Participants
|
|
Smoking History
Former Smoker
|
24 participants
n=93 Participants
|
|
Smoking History
Never a Smoker
|
3 participants
n=93 Participants
|
|
Previous Treatment
1 Chemotherapy
|
26 participants
n=93 Participants
|
|
Previous Treatment
2 Chemotherapy
|
5 participants
n=93 Participants
|
|
Previous Treatment
>2 Chemotherapy
|
2 participants
n=93 Participants
|
|
Previous Treatment
Previous Targeted Therapy
|
6 participants
n=93 Participants
|
|
Previous Treatment
Previous radiotherapy
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 12 participants participated in the phase I portion of the trial.
The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
Outcome measures
| Measure |
Investigational Treatment
n=12 Participants
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
|
750 mg/m^2 every 21 days
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: 27 participants had enough data to complete TTP analysis
The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the 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
Outcome measures
| Measure |
Investigational Treatment
n=27 Participants
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Time To Progression (TTP)
|
14.6 Weeks
Interval 6.0 to 78.7
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: 27 participants had data sufficient to complete Median Survival Time analysis
Outcome measures
| Measure |
Investigational Treatment
n=27 Participants
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Median Survival Time
|
42.0 weeks
Interval 8.6 to 103.9
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Investigational Treatment
n=33 Participants
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Toxicity and Safety Profile
Acne-like rash: Phase I - Any Grade
|
58.3 percentage of particpants
|
|
Toxicity and Safety Profile
Acne-like rash: Phase I - Grade 3/4
|
16.7 percentage of particpants
|
|
Toxicity and Safety Profile
Acne-like rash: Phase II - Any Grade
|
57 percentage of particpants
|
|
Toxicity and Safety Profile
Acne-like rash: Phase II - Grade 3/4
|
23.8 percentage of particpants
|
|
Toxicity and Safety Profile
ALT elevation: Phase I - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
ALT elevation: Phase I - Grade 3/4
|
16.7 percentage of particpants
|
|
Toxicity and Safety Profile
ALT elevation: Phase II - Any Grade
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
ALT elevation: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Anemia: Phase I - Any Grade
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Anemia: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Anemia: Phase II - Any Grade
|
14.3 percentage of particpants
|
|
Toxicity and Safety Profile
Anemia: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Thrombocytopenia: Phase I - Any Grade
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Thrombocytopenia: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Thrombocytopenia: Phase II - Any Grade
|
14.3 percentage of particpants
|
|
Toxicity and Safety Profile
Thrombocytopenia: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Neutropenia: Phase I - Any Grade
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Neutropenia: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Neutropenia: Phase II - Any Grade
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Neutropenia: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Febrile Neutropenia: Phase I - Any Grade
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Febrile Neutropenia: Phase I - Grade 3/4
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Febrile Neutropenia: Phase II - Any Grade
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Febrile Neutropenia: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Dizziness: Phase I - Any Grade
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Dizziness: Phase I - Grade 3/4
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Dizziness: Phase II - Any Grade
|
19 percentage of particpants
|
|
Toxicity and Safety Profile
Dizziness: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Dyspnea: Phase I - Any Grade
|
25 percentage of particpants
|
|
Toxicity and Safety Profile
Dyspnea: Phase I - Grade 3/4
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Dyspnea: Phase II - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Dyspnea: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Cough: Phase I - Any Grade
|
25 percentage of particpants
|
|
Toxicity and Safety Profile
Cough: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Cough: Phase II - Any Grade
|
28.6 percentage of particpants
|
|
Toxicity and Safety Profile
Cough: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Fatigue: Phase I - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Fatigue: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Fatigue: Phase II - Any Grade
|
76 percentage of particpants
|
|
Toxicity and Safety Profile
Fatigue: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Anorexia: Phase I - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Anorexia: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Anorexia: Phase II - Any Grade
|
19 percentage of particpants
|
|
Toxicity and Safety Profile
Anorexia: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Mucositis: Phase I - Any Grade
|
41.7 percentage of particpants
|
|
Toxicity and Safety Profile
Mucositis: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Mucositis: Phase II - Any Grade
|
38 percentage of particpants
|
|
Toxicity and Safety Profile
Mucositis: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Nausea: Phase I - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Nausea: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Nausea: Phase II - Any Grade
|
28.6 percentage of particpants
|
|
Toxicity and Safety Profile
Nausea: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Diarrhea: Phase I - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Diarrhea: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Diarrhea: Phase II - Any Grade
|
33.3 percentage of particpants
|
|
Toxicity and Safety Profile
Diarrhea: Phase II - Grade 3/4
|
9.5 percentage of particpants
|
|
Toxicity and Safety Profile
Constipation: Phase I - Any Grade
|
16.7 percentage of particpants
|
|
Toxicity and Safety Profile
Constipation: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Constipation: Phase II - Any Grade
|
23.8 percentage of particpants
|
|
Toxicity and Safety Profile
Constipation: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Fever(no neutropenia): Phase I - Any Grade
|
8.3 percentage of particpants
|
|
Toxicity and Safety Profile
Fever(no neutropenia): Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Fever(no neutropenia): Phase II - Any Grade
|
19 percentage of particpants
|
|
Toxicity and Safety Profile
Fever(no neutropenia): Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Headache: Phase I - Any Grade
|
50 percentage of particpants
|
|
Toxicity and Safety Profile
Headache: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Headache: Phase II - Any Grade
|
23.8 percentage of particpants
|
|
Toxicity and Safety Profile
Headache: Phase II - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Hypomagnesmia: Phase I - Any Grade
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Hypomagnesmia: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Hypomagnesmia: Phase II - Any Grade
|
19 percentage of particpants
|
|
Toxicity and Safety Profile
Hypomagnesmia: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
|
Toxicity and Safety Profile
Vomiting: Phase I - Any Grade
|
16.7 percentage of particpants
|
|
Toxicity and Safety Profile
Vomiting: Phase I - Grade 3/4
|
0 percentage of particpants
|
|
Toxicity and Safety Profile
Vomiting: Phase II - Any Grade
|
23.8 percentage of particpants
|
|
Toxicity and Safety Profile
Vomiting: Phase II - Grade 3/4
|
4.8 percentage of particpants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was not collected or analyzed for this secondary objective.
Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)
Outcome measures
Outcome data not reported
Adverse Events
Pemetrexed + Cetuximab
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Cetuximab
n=36 participants at risk
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Nervous system disorders
CNS CEREBROVASCULAR ISCHEMIA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / DISEASE PROGRESSION NOS
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
DEHYDRATION
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
DIZZINESS
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BONE (OSTEOMYELITIS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Surgical and medical procedures
PTT (PARTIAL THROMBOPLASTIN TIME)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
Other adverse events
| Measure |
Pemetrexed + Cetuximab
n=36 participants at risk
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles
Cetuximab: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
11.1%
4/36 • Number of events 9 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
ANOREXIA
|
36.1%
13/36 • Number of events 18 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
8.3%
3/36 • Number of events 12 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
2.8%
1/36 • Number of events 4 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
COAGULATION - OTHER
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
CONFUSION
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.4%
7/36 • Number of events 11 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
30.6%
11/36 • Number of events 16 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
DEHYDRATION
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
DIARRHEA
|
22.2%
8/36 • Number of events 9 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
DIZZINESS
|
8.3%
3/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
33.3%
12/36 • Number of events 22 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
EDEMA: HEAD AND NECK
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
5.6%
2/36 • Number of events 5 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Eye disorders
EYELID DYSFUNCTION
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
58.3%
21/36 • Number of events 57 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
16.7%
6/36 • Number of events 9 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
8.3%
3/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
22.2%
8/36 • Number of events 12 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
16.7%
6/36 • Number of events 8 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
11.1%
4/36 • Number of events 8 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / ANUS
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / UNGUAL (NAILS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION - OTHER
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / CONJUNCTIVA
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / MUCOSA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
INSOMNIA
|
11.1%
4/36 • Number of events 6 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
8.3%
3/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
METABOLIC/LABORATORY - OTHER
|
5.6%
2/36 • Number of events 7 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
8.3%
3/36 • Number of events 4 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
30.6%
11/36 • Number of events 17 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / PHARYNX
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
2.8%
1/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
11.1%
4/36 • Number of events 6 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
27.8%
10/36 • Number of events 23 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
NEUROPATHY: CRANIAL / CN VIII HEARING AND BALANCE
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
22.2%
8/36 • Number of events 9 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
5.6%
2/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Ear and labyrinth disorders
OTITIS, EXTERNAL EAR (NON-INFECTIOUS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
8.3%
3/36 • Number of events 4 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
PAIN / BACK
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
5.6%
2/36 • Number of events 4 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
8.3%
3/36 • Number of events 4 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
PAIN / FACE
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
PAIN / HEAD/HEADACHE
|
25.0%
9/36 • Number of events 10 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / PLEURA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
PAIN / TUMOR PAIN
|
2.8%
1/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Renal and urinary disorders
PAIN / URETHRA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
PAIN - OTHER
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Vascular disorders
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
|
2.8%
1/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Blood and lymphatic system disorders
PLATELETS
|
11.1%
4/36 • Number of events 7 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
PROCTITIS
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
22.2%
8/36 • Number of events 10 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
8.3%
3/36 • Number of events 6 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
50.0%
18/36 • Number of events 56 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
2.8%
1/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
RIGORS/CHILLS
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
SKIN BREAKDOWN/DECUBITUS ULCER
|
5.6%
2/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
SWEATING (DIAPHORESIS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
13.9%
5/36 • Number of events 8 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Nervous system disorders
TREMOR
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
5.6%
2/36 • Number of events 2 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Skin and subcutaneous tissue disorders
URTICARIA (HIVES, WELTS, WHEALS)
|
2.8%
1/36 • Number of events 1 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
Gastrointestinal disorders
VOMITING
|
19.4%
7/36 • Number of events 8 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
|
General disorders
WEIGHT LOSS
|
5.6%
2/36 • Number of events 3 • Participants were monitored for adverse events for the duration of their participation in the trial, generally up to one year.
Adverse Events are reported for all 36 participants that consented for the study, although 33 participants actually received treatment.
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place