Trial Outcomes & Findings for Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer (NCT NCT01633541)
NCT ID: NCT01633541
Last Updated: 2023-07-20
Results Overview
The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to 3 months after end of treatment
Results posted on
2023-07-20
Participant Flow
one subject was enrolled; however, disease progression was discovered before active treatment and therefore the patient never was treated with study drug
Participant milestones
| Measure |
Platinum/Docetaxal + AT-101
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
18
|
|
Overall Study
COMPLETED
|
35
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Platinum/Docetaxal + AT-101
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
Baseline characteristics by cohort
| Measure |
Platinum/Docetaxal + AT-101
n=36 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
Per physician discretion, carboplatin was used in lieu of cisplatin for 13 patients in this arm
|
Active Comparator Arm
n=18 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Per physician discretion, carboplatin was used in lieu of cisplatin for 10 patients in this arm Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
58.5 years
n=99 Participants
|
61.4 years
n=107 Participants
|
59.95 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=99 Participants
|
18 participants
n=107 Participants
|
54 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after end of treatmentThe primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=34 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment
|
27 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years after randomizationTime from randomization to the time of first indication of local failure or metastases. Estimated non-parametrically using the Kaplan-Meier method.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=31 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=15 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Progression-free Survival
|
55 percentage of participants
Interval 35.0 to 71.0
|
65 percentage of participants
Interval 36.0 to 84.0
|
PRIMARY outcome
Timeframe: Up to approximately 60 daysPopulation: This outcome measure only applies to those subjects treated with induction chemotherapy with platinum and docetaxel plus AT-101 and therefore only one arm is being reported
ORR (Complete Response \[CR\] plus Partial Response \[PR\]) to induction chemotherapy with platinum and docetaxel plus AT-101 following one and/or two cycles in patients with advanced laryngeal cancer.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=36 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Overall Response Rate (ORR)
|
27 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 3 years after end of treatmentToxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=36 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events.
|
61 percentage of Patients
|
44 percentage of Patients
|
SECONDARY outcome
Timeframe: Up to 28 months post treatmentPopulation: Number of participants analyzed varies below based on completion compliance
University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=36 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Head and Neck Related Quality of Life (QOL)
Emotion- Prior to treatment
|
66.7 units on a scale
Interval 41.7 to 79.2
|
62.5 units on a scale
Interval 58.3 to 75.0
|
|
Head and Neck Related Quality of Life (QOL)
Emotion- 6 months
|
66.7 units on a scale
Interval 41.7 to 95.8
|
95.8 units on a scale
Interval 75.0 to 100.0
|
|
Head and Neck Related Quality of Life (QOL)
Emotion- 12 months
|
72.9 units on a scale
Interval 66.7 to 83.3
|
91.7 units on a scale
Interval 75.0 to 100.0
|
|
Head and Neck Related Quality of Life (QOL)
Emotion- 24 months
|
75 units on a scale
Interval 52.1 to 81.3
|
91.7 units on a scale
Interval 91.7 to 95.8
|
|
Head and Neck Related Quality of Life (QOL)
Speech- Prior to treatment
|
46.9 units on a scale
Interval 37.5 to 62.5
|
34.4 units on a scale
Interval 25.0 to 68.8
|
|
Head and Neck Related Quality of Life (QOL)
Speech- 6 Months
|
56.3 units on a scale
Interval 21.9 to 78.1
|
50 units on a scale
Interval 37.5 to 81.3
|
|
Head and Neck Related Quality of Life (QOL)
Speech- 12 Months
|
50 units on a scale
Interval 31.3 to 75.0
|
62.5 units on a scale
Interval 18.8 to 87.5
|
|
Head and Neck Related Quality of Life (QOL)
Speech- 24 Months
|
50 units on a scale
Interval 43.8 to 75.0
|
75 units on a scale
Interval 50.0 to 87.5
|
|
Head and Neck Related Quality of Life (QOL)
Pain- Prior to treatment
|
59.4 units on a scale
Interval 43.8 to 75.0
|
68.8 units on a scale
Interval 56.3 to 87.5
|
|
Head and Neck Related Quality of Life (QOL)
Pain- 6 months
|
62.5 units on a scale
Interval 31.3 to 87.5
|
81.3 units on a scale
Interval 62.5 to 87.5
|
|
Head and Neck Related Quality of Life (QOL)
Pain- 12 months
|
68.8 units on a scale
Interval 43.8 to 91.7
|
62.5 units on a scale
Interval 58.3 to 87.5
|
|
Head and Neck Related Quality of Life (QOL)
Pain- 24 months
|
56.3 units on a scale
Interval 28.1 to 87.5
|
87.5 units on a scale
Interval 75.0 to 93.8
|
SECONDARY outcome
Timeframe: Up to 28 months post treatmentPopulation: number of participants analyzed varies due to patient compliance and patients coming off trial per protocol
The University of Michigan Voice Related Quality of Life Measure (V-RQOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-50 (10 items scale 1-5) with high scores indicating a worse outcome.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=35 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=17 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Voice Related QOL
TROUBLEPHONE_VAL_6n- 24 Months
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Voice Related QOL
TROUBLEJOB_VAL_7n- Prior to treatment
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
TROUBLEJOB_VAL_7n- 6 Months
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
TROUBLEJOB_VAL_7n- 12 Months
|
2.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
TROUBLEJOB_VAL_7n- 24 Months
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
AVOIDSOCIALLY_VAL_8n- Prior to treatment
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
AVOIDSOCIALLY_VAL_8n- 6 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
AVOIDSOCIALLY_VAL_8n- 12 months
|
1.5 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
AVOIDSOCIALLY_VAL_8n- 24 months
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
REPEATMYSELF_VAL_9n- Prior to treatment
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Voice Related QOL
REPEATMYSELF_VAL_9n- 6 months
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Voice Related QOL
REPEATMYSELF_VAL_9n- 12 months
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Voice Related QOL
REPEATMYSELF_VAL_9n- 24 months
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Voice Related QOL
LESSOUTGOING_VAL_10n- Prior to treatment
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
LESSOUTGOING_VAL_10n- 6 months
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
LESSOUTGOING_VAL_10n- 12 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
LESSOUTGOING_VAL_10n- 24 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
VRQOL-SUM- Prior to treatment
|
25 score on a scale
Interval 18.0 to 29.0
|
24 score on a scale
Interval 20.0 to 34.0
|
|
Voice Related QOL
VRQOL-SUM- 6 Months
|
23 score on a scale
Interval 13.0 to 32.0
|
23 score on a scale
Interval 14.0 to 28.0
|
|
Voice Related QOL
OUTOFAIR_VAL- 12 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
WHATCOMEOUT_VAL_3n- 12 months
|
2 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
WHATCOMEOUT_VAL_3n- 24 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
ANXIOUS_VAL_4n- 24 months
|
3 score on a scale
Interval 2.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
DEPRESSED_VAL_5n- Prior to treatment
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
DEPRESSED_VAL_5n- 6 months
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
DEPRESSED_VAL_5n- 12 months
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Voice Related QOL
DEPRESSED_VAL_5n- 24 months
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Voice Related QOL
TROUBLEPHONE_VAL_6n- Prior to treatment
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 3.0 to 4.0
|
|
Voice Related QOL
TROUBLEPHONE_VAL_6n- 6 Months
|
2 score on a scale
Interval 2.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Voice Related QOL
TROUBLEPHONE_VAL_6n- 12 Months
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
VRQOL-SUM- 12 Months
|
26 score on a scale
Interval 17.0 to 32.5
|
22 score on a scale
Interval 13.0 to 31.0
|
|
Voice Related QOL
VRQOL-SUM- 24 Months
|
22 score on a scale
Interval 15.0 to 32.0
|
21 score on a scale
Interval 15.0 to 23.0
|
|
Voice Related QOL
NOISY_VAL_- Prior to treatment
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Voice Related QOL
NOISY_VAL_- 6months
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Voice Related QOL
NOISY_VAL_- 12 months
|
4 score on a scale
Interval 3.0 to 4.5
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Voice Related QOL
NOISY_VAL_- 24 months
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Voice Related QOL
OUTOFAIR_VAL- Prior to treatment
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
OUTOFAIR_VAL- 6 months
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
OUTOFAIR_VAL- 24 months
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
WHATCOMEOUT_VAL_3n- Prior to treatment
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
WHATCOMEOUT_VAL_3n- 6 months
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
ANXIOUS_VAL_4n- Prior to treatment
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Voice Related QOL
ANXIOUS_VAL_4n- 6 months
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Voice Related QOL
ANXIOUS_VAL_4n- 12 months
|
2.5 score on a scale
Interval 2.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 28 months post treatmentPopulation: Number of participants analyzed varies below based on completion compliance
University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome. EATING Domain is reported here as a functional assessment.
Outcome measures
| Measure |
Platinum/Docetaxal + AT-101
n=36 Participants
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients will receive AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 Participants
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Functional Assessment QOL
EATING- Prior to treatment
|
83.3 score on a scale
Interval 64.6 to 93.8
|
91.7 score on a scale
Interval 83.3 to 100.0
|
|
Functional Assessment QOL
EATING- 6 months
|
75 score on a scale
Interval 60.4 to 85.4
|
83.3 score on a scale
Interval 75.0 to 87.5
|
|
Functional Assessment QOL
EATING- 12 months
|
83.3 score on a scale
Interval 66.7 to 91.7
|
83.3 score on a scale
Interval 62.5 to 87.5
|
|
Functional Assessment QOL
EATING- 24 months
|
77.1 score on a scale
Interval 67.7 to 87.5
|
95.8 score on a scale
Interval 75.0 to 95.8
|
Adverse Events
Platinum/Docetaxal + AT-101
Serious events: 14 serious events
Other events: 36 other events
Deaths: 1 deaths
Active Comparator Arm
Serious events: 5 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Platinum/Docetaxal + AT-101
n=36 participants at risk
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients received AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 participants at risk
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Allergic reaction
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Colitis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Psychiatric disorders
Confusion
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Disease Progression
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma - Nose
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
3/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Renal and urinary disorders
Acute Kidney injury
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hyperkalemia
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypokalemia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Infection, Lung (pneumonia)
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Infection, Upper aerodigestive NOS
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Infection, Upper airway NOS
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Blood and lymphatic system disorders
Intracranial hemorrhage
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Neck pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
neutropenia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Seizure
|
2.8%
1/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Cardiac disorders
pulmonary embolism
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Blood and lymphatic system disorders
Tracheal hemorrhage
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
Other adverse events
| Measure |
Platinum/Docetaxal + AT-101
n=36 participants at risk
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.
Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
(AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.
AT-101: Patients received AT-101 40 mg orally two times a day.
Cisplatin: Cisplatin 100 mg/m2
Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
Active Comparator Arm
n=18 participants at risk
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).
Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.
Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Acne
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Alkaline phosphatase increased
|
2.8%
1/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Immune system disorders
Allergic reaction
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
7/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
27.8%
5/18 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Psychiatric disorders
Anxiety
|
25.0%
9/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Aspartate aminotransferase increased
|
13.9%
5/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Eye disorders
Blurred vision
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Colitis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Constipation
|
27.8%
10/36 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
50.0%
9/18 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Constitutional Symptoms - Other (Specify)
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Creatinine increased
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Psychiatric disorders
Depression
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Dermal change
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
19.4%
7/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
16/36 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
33.3%
6/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Dizziness
|
19.4%
7/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
22.2%
4/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Dry mouth
|
44.4%
16/36 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
33.3%
6/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Dysphagia
|
41.7%
15/36 • Number of events 23 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
38.9%
7/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.9%
5/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
22.2%
4/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Ear and labyrinth disorders
Ear pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Ear and labyrinth disorders
Ear, nose and throat examination abnormal
|
19.4%
7/36 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Edema limbs
|
16.7%
6/36 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Edema: head and neck
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Edema: viscera
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Erythema multiforme
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Esophageal pain
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Esophagitis
|
22.2%
8/36 • Number of events 14 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Ear and labyrinth disorders
External ear pain
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Fatigue
|
41.7%
15/36 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
55.6%
10/18 • Number of events 13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Fever
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Flu-like syndrome
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Fracture
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
GI - Other (Specify)
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Hand-and-foot syndrome
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Headache
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Heartburn
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hemoglobin decrease
|
16.7%
6/36 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
33.3%
6/18 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Blood and lymphatic system disorders
Hemorrhage - Other (Specify)
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hyperbilirubinemia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypercalcemia
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hyperglycemia
|
11.1%
4/36 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hyperkalemia
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypoalbuminemia
|
5.6%
2/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypocalcemia
|
11.1%
4/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypokalemia
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hypomagnesemia
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Hyponatremia
|
11.1%
4/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Infection - Other (Specify)
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Eye disorders
Intraoperative ocular injury
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Involuntary movement
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Joint pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Laryngoscopy abnormal
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Lymphocyte count decreased
|
22.2%
8/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
38.9%
7/18 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.9%
5/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other (Specify)
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Nausea
|
63.9%
23/36 • Number of events 43 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
61.1%
11/18 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
neutropenia
|
13.9%
5/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Nystagmus
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Oral pain
|
19.4%
7/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Pain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Periodontal disease
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
4/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
22.2%
8/36 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
38.9%
7/18 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Platelet count decreased
|
27.8%
10/36 • Number of events 15 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
22.2%
4/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Radiation recall reaction (dermatologic)
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
8/36 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
22.2%
4/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
chills
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Seizure
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Vascular disorders
Sinus bradycardia
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Skin infection
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Taste alteration
|
58.3%
21/36 • Number of events 25 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
33.3%
6/18 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Ear and labyrinth disorders
Tinnitus
|
22.2%
8/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
27.8%
5/18 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Toothache
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Tracheostomy site bleeding
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
5.6%
1/18 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Tumor pain
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Infections and infestations
Vaginal infection
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
General disorders
Voice alteration
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
13/36 • Number of events 19 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
11.1%
2/18 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Weight gain
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
0.00%
0/18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
|
Investigations
Weight loss
|
33.3%
12/36 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
16.7%
3/18 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
|
Additional Information
Dr. Paul Swiecicki
University of Michigan Rogel Cancer Center
Phone: 734-647-1017
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place