Trial Outcomes & Findings for A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma (NCT NCT00874614)
NCT ID: NCT00874614
Last Updated: 2020-02-20
Results Overview
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
12 months
Results posted on
2020-02-20
Participant Flow
Participant milestones
| Measure |
AZEDRA® (Iobenguane I 131)
Patients received dosimetric dose (\~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
Received at Least One Therapeutic Dose
|
68
|
|
Overall Study
Received Two Therapeutic Doses
|
50
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Baseline characteristics by cohort
| Measure |
AZEDRA® (Iobenguane I 131)
n=68 Participants
Patients received dosimetric dose (\~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
|
|---|---|
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Age, Continuous
|
55 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
AZEDRA® (Iobenguane I 131)
n=68 Participants
Patients received at least one therapeutic dose of AZEDRA®.
|
Two Therapeutic Doses of AZEDRA®
Patients received two therapeutic doses of AZEDRA®.
|
|---|---|---|
|
Percentage of Patients Who Experienced a 50% or Greater Reduction (Including Discontinuation) of All Antihypertensive Medication(s) Lasting for at Least Six Months.
|
25 percentage of patients
Interval 16.0 to 37.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 64 patients with tumor measurements evaluable for tumor response.
Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 was assessed by two independent central reviewers and one adjudicator, and overall response (PR or CR) was confirmed by follow-up imaging at the subsequent timepoint. Complete response was defined as confirmed disappearance of all target lesions and Partial Response was defined as confirmed decreased of \>= 30% in baseline sum of the longest diameter of target lesions.
Outcome measures
| Measure |
AZEDRA® (Iobenguane I 131)
n=64 Participants
Patients received at least one therapeutic dose of AZEDRA®.
|
Two Therapeutic Doses of AZEDRA®
Patients received two therapeutic doses of AZEDRA®.
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|---|---|---|
|
Best Confirmed Overall Tumor Response of Complete Response (CR) or Partial Response (PR) by RECIST 1.0.
|
23.4 percentage of patients
Interval 15.0 to 35.0
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 53 patients with data available.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 v.3 was used to evaluate QoL. This questionnaire was comprised of 30 questions, two of which pertain to a patient's Global Health Status and QoL. The two questions used a 7-point Likert scale of 1 (very poor) to 7 (excellent), in which the scores were averaged and linearly transformed to a 0-100 scale with higher scores indicating better health status and QoL. The questionnaire was administered at baseline and through 12 months after the first therapeutic dose of AZEDRA®. The results of QoL and changes from baseline were summarized by visit and the best response within 12 months after first therapeutic dose of AZEDRA® was reported. The outcome represents the mean change from baseline in overall QoL based on the best response reported within 12 months after first therapeutic dose of AZEDRA®.
Outcome measures
| Measure |
AZEDRA® (Iobenguane I 131)
n=53 Participants
Patients received at least one therapeutic dose of AZEDRA®.
|
Two Therapeutic Doses of AZEDRA®
Patients received two therapeutic doses of AZEDRA®.
|
|---|---|---|
|
Changes From Baseline in Overall Quality of Life (QoL) - Best Response Within 12 Months After First Therapeutic Dose of AZEDRA®.
|
17.5 score on a scale
Standard Deviation 18.12
|
—
|
SECONDARY outcome
Timeframe: Up to 5 Years (60 months)Duration of overall survival was calculated from the date of first therapeutic dose of AZEDRA® to death, or at the last date the patient was known to be alive. Results are presented per December 2017 data-cut. Survival was censored at the end of the 5-year long-term follow-up period, thus the upper limit of the confidence interval reported below for two therapeutic doses is actually \>60 months.
Outcome measures
| Measure |
AZEDRA® (Iobenguane I 131)
n=68 Participants
Patients received at least one therapeutic dose of AZEDRA®.
|
Two Therapeutic Doses of AZEDRA®
n=50 Participants
Patients received two therapeutic doses of AZEDRA®.
|
|---|---|---|
|
Overall Survival
|
37 months
Interval 31.0 to 49.0
|
44 months
Interval 32.0 to 60.0
|
Adverse Events
AZEDRA® (Iobenguane I 131)
Serious events: 32 serious events
Other events: 69 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
AZEDRA® (Iobenguane I 131)
n=74 participants at risk
Patients who received any dose of AZEDRA® (N=74). All-cause mortality was followed in patients who received at least one therapeutic dose of AZEDRA® (N=68), up through long-term follow-up as of December 2017.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
4.1%
3/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.1%
3/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Sickle cell anemia with crisis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.2%
12/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
3/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
3/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Convulsion
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Dyskinesia
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Seizure
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Spinal cord compression
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Renal and urinary disorders
Kidney fibrosis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Cardiac disorders
Cardiomyopathy
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Sepsis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Platelet count decreased
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Psychiatric disorders
Suicide attempt
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Vascular disorders
Hypertensive crisis
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Vascular disorders
Hypotension
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Disease progression
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
1.4%
1/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
Other adverse events
| Measure |
AZEDRA® (Iobenguane I 131)
n=74 participants at risk
Patients who received any dose of AZEDRA® (N=74). All-cause mortality was followed in patients who received at least one therapeutic dose of AZEDRA® (N=68), up through long-term follow-up as of December 2017.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
71.6%
53/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
48.6%
36/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
37.8%
28/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Constipation
|
21.6%
16/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
21.6%
16/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
14/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Retching
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.2%
49/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
58.1%
43/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
55.4%
41/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.7%
39/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.5%
10/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Fatigue
|
55.4%
41/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Asthenia
|
18.9%
14/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Pyrexia
|
12.2%
9/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Dizziness
|
37.8%
28/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Headache
|
28.4%
21/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Syncope
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
White blood cell count decreased
|
16.2%
12/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
International normalized ratio increased
|
14.9%
11/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Neutrophil count decreased
|
13.5%
10/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
12.2%
9/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Hemoglobin decreased
|
9.5%
7/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Platelet count decreased
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Vascular disorders
Hypotension
|
24.3%
18/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Vascular disorders
Hypertension
|
17.6%
13/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.9%
14/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.0%
17/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.2%
9/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Cardiac disorders
Tachycardia
|
9.5%
7/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Salivary gland pain
|
13.5%
10/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Edema peripheral
|
12.2%
9/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Infusion site pain
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Injection site pain
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Chills
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
General disorders
Chest pain
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Dysgeusia
|
17.6%
13/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Nervous system disorders
Paraesthesia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Weight decreased
|
14.9%
11/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Prothrombin time prolonged
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Lymphocyte count decreased
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Blood creatinine increased
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Red blood cell count decreased
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Investigations
Hematocrit decreased
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Sialoadenitis
|
18.9%
14/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Urinary tract infection
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Candida infection
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Infections and infestations
Sinusitis
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Vascular disorders
Orthostatic hypotension
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
11/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.5%
10/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
10/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.2%
9/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
5/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
7/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Psychiatric disorders
Insomnia
|
9.5%
7/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Psychiatric disorders
Anxiety
|
5.4%
4/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Cardiac disorders
Palpitations
|
10.8%
8/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
|
Renal and urinary disorders
Proteinuria
|
8.1%
6/74 • All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60