Trial Outcomes & Findings for Bevacizumab Beyond Progression (BBP) (NCT NCT01740258)
NCT ID: NCT01740258
Last Updated: 2021-01-26
Results Overview
To assess the effect on overall survival of continuing bevacizumab treatment after disease progression in patients treated with bevacizumab from the time of first diagnosis of grade IV malignant glioma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
5 Years
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
Entered Part A
|
68
|
|
Overall Study
Entered Part B
|
62
|
|
Overall Study
Entered Part C
|
20
|
|
Overall Study
Entered Part D
|
42
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab Beyond Progression (BBP)
Baseline characteristics by cohort
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 Participants
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 YearsTo assess the effect on overall survival of continuing bevacizumab treatment after disease progression in patients treated with bevacizumab from the time of first diagnosis of grade IV malignant glioma.
Outcome measures
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 Participants
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Overall Survival
|
17.8 months
Interval 15.2 to 23.2
|
SECONDARY outcome
Timeframe: 5 YearsThe occurrence of ≥ grade 2 CNS (central nervous system) hemorrhage or grade 4 or 5 non-hematologic toxicity is defined as being unacceptable. "Unacceptable" toxicity rates of 5% or less are considered desirable, while rates of 20% or greater are considered as undesirable.
Outcome measures
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 Participants
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Toxicity: Percentage of Subjects With Unacceptable Toxicities
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: 5 YearsTo assess the effect on progression-free survival of continuing bevacizumab treatment after disease progression in patients treated with bevacizumab from the time of initiation of treatment to the first occurrence of progression, or death
Outcome measures
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 Participants
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Progression-free Survival (PFS)
|
9.9 months
Interval 8.8 to 13.6
|
Adverse Events
Bevaczimab, Radiation Therapy, Temozolomide
Serious events: 41 serious events
Other events: 68 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 participants at risk
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
2/68 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/68 • 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Colonic perforation
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/68 • 5 years
|
|
General disorders
Death NOS
|
11.8%
8/68 • 5 years
|
|
General disorders
Fatigue
|
2.9%
2/68 • 5 years
|
|
General disorders
Fever
|
7.4%
5/68 • 5 years
|
|
General disorders
Gait disturbance
|
1.5%
1/68 • 5 years
|
|
General disorders
Localized edema
|
1.5%
1/68 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/68 • 5 years
|
|
Immune system disorders
Allergic reaction
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: R PERI-TONSILLAR ABSCESS; CPT-11
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: ULCERATIVE VIRAL L TONSILLITIS
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: VIRAL SEPSIS SYNDROME
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Lung infection
|
4.4%
3/68 • 5 years
|
|
Infections and infestations
Rash pustular
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Sepsis
|
2.9%
2/68 • 5 years
|
|
Infections and infestations
Skin infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Wound infection
|
1.5%
1/68 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/68 • 5 years
|
|
Investigations
Neutrophil count decreased
|
5.9%
4/68 • 5 years
|
|
Investigations
Platelet count decreased
|
11.8%
8/68 • 5 years
|
|
Investigations
White blood cell decreased
|
2.9%
2/68 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
1/68 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.5%
1/68 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.4%
3/68 • 5 years
|
|
Nervous system disorders
Ataxia
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Dysphasia
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Headache
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Pyramidal tract syndrome
|
8.8%
6/68 • 5 years
|
|
Nervous system disorders
Seizure
|
22.1%
15/68 • 5 years
|
|
Nervous system disorders
Stroke
|
2.9%
2/68 • 5 years
|
|
Psychiatric disorders
Confusion
|
1.5%
1/68 • 5 years
|
|
Psychiatric disorders
Delirium
|
4.4%
3/68 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
10.3%
7/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.5%
1/68 • 5 years
|
|
Vascular disorders
Hypertension
|
10.3%
7/68 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
5.9%
4/68 • 5 years
|
Other adverse events
| Measure |
Bevaczimab, Radiation Therapy, Temozolomide
n=68 participants at risk
In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks.
If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle.
If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks.
If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.
Radiation Therapy
Temozolomide
Bevacizumab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.2%
45/68 • 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Conduction disorder
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Mitral valve disease
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
1/68 • 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: FULLNESS IN LEFT EAR-RADIATION
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: L EAR CLOGGED; XRT
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: WAX IMPACTION
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
2/68 • 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
1/68 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/68 • 5 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify: HYPOTESTOSTERONEMIA
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Blurred vision
|
14.7%
10/68 • 5 years
|
|
Eye disorders
Cataract
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Dry eye
|
2.9%
2/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: DIPLOPIA
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: EYE STRAIN
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: FLOATER VS. SMUDGE; XRT
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: HOMONYMOUS HEMIANOPSIA; RIGHT EYE
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: L EYE TWITCH FROM EYE STRAIN
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: L HOMONYMOUS HEMIANOPSIA
|
2.9%
2/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: MOMENTARY LOSS OF VISION IN L EYE
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: OPTIC NERVE NEUROPATHY; AVASTIN
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: PERIPHERAL VISION LOSS
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: R VISUAL FIELD CUT
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: R VISUAL FIELD CUT, DISEASE PROGRESSION
|
1.5%
1/68 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify: RU QUADRANOPSIA
|
2.9%
2/68 • 5 years
|
|
Eye disorders
Photophobia
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
8/68 • 5 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
4.4%
3/68 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
72.1%
49/68 • 5 years
|
|
Gastrointestinal disorders
Dental caries
|
4.4%
3/68 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
48.5%
33/68 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
6/68 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
4/68 • 5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
10.3%
7/68 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
4/68 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.4%
3/68 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: ABSCESSED WISDOM TOOTH
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: CHIPPED TOOTH
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: RECTAL BLEEDING; AVASTIN
|
1.5%
1/68 • 5 years
|
|
Gastrointestinal disorders
Gingival pain
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.4%
5/68 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
23.5%
16/68 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
61.8%
42/68 • 5 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.4%
3/68 • 5 years
|
|
Gastrointestinal disorders
Periodontal disease
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Toothache
|
2.9%
2/68 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
33.8%
23/68 • 5 years
|
|
General disorders
Chills
|
1.5%
1/68 • 5 years
|
|
General disorders
Death NOS
|
16.2%
11/68 • 5 years
|
|
General disorders
Edema limbs
|
17.6%
12/68 • 5 years
|
|
General disorders
Fatigue
|
92.6%
63/68 • 5 years
|
|
General disorders
Fever
|
19.1%
13/68 • 5 years
|
|
General disorders
Flu like symptoms
|
7.4%
5/68 • 5 years
|
|
General disorders
Gait disturbance
|
5.9%
4/68 • 5 years
|
|
General disorders
Other, specify: DUE TO STEROIDS, INTERMITTENT DIAPHORESIS, LIGHTHEADEDNESS AND HYPERTENSION
|
1.5%
1/68 • 5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify: FEELS COLD
|
1.5%
1/68 • 5 years
|
|
General disorders
Infusion site extravasation
|
1.5%
1/68 • 5 years
|
|
General disorders
Injection site reaction
|
1.5%
1/68 • 5 years
|
|
General disorders
Irritability
|
5.9%
4/68 • 5 years
|
|
General disorders
Localized edema
|
1.5%
1/68 • 5 years
|
|
General disorders
Neck edema
|
1.5%
1/68 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.9%
2/68 • 5 years
|
|
General disorders
Pain
|
14.7%
10/68 • 5 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
1.5%
1/68 • 5 years
|
|
Immune system disorders
Allergic reaction
|
5.9%
4/68 • 5 years
|
|
Infections and infestations
Bronchial infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: COLD SORES
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: GOUT
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: LYME'S DX
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: RLE CELLULITIS
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: SHINGLES
|
4.4%
3/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: TRIGEMINAL HERPES ZOSTER
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify: ULCERATIVE VIRAL L TONSILLITIS
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Lung infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Lymph gland infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Mucosal infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Nail infection
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Otitis externa
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Otitis media
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Papulopustular rash
|
2.9%
2/68 • 5 years
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/68 • 5 years
|
|
Infections and infestations
Sinusitis
|
16.2%
11/68 • 5 years
|
|
Infections and infestations
Skin infection
|
5.9%
4/68 • 5 years
|
|
Infections and infestations
Tooth infection
|
2.9%
2/68 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
14.7%
10/68 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
14.7%
10/68 • 5 years
|
|
Infections and infestations
Vaginal infection
|
1.5%
1/68 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
1.5%
1/68 • 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.9%
4/68 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
14.7%
10/68 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.9%
2/68 • 5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: ABDOMINAL BRUISING AT INJECTION
|
1.5%
1/68 • 5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: BRUISING ON RIGHT THUMB
|
1.5%
1/68 • 5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: HAND PUNCTURE
|
1.5%
1/68 • 5 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.9%
2/68 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
60.3%
41/68 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
23.5%
16/68 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
54.4%
37/68 • 5 years
|
|
Investigations
Blood bilirubin increased
|
26.5%
18/68 • 5 years
|
|
Investigations
Cholesterol high
|
1.5%
1/68 • 5 years
|
|
Investigations
Creatinine increased
|
26.5%
18/68 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
77.9%
53/68 • 5 years
|
|
Investigations
Neutrophil count decreased
|
66.2%
45/68 • 5 years
|
|
Investigations
Platelet count decreased
|
86.8%
59/68 • 5 years
|
|
Investigations
Weight gain
|
2.9%
2/68 • 5 years
|
|
Investigations
Weight loss
|
5.9%
4/68 • 5 years
|
|
Investigations
White blood cell decreased
|
75.0%
51/68 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
26.5%
18/68 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
7/68 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
88.2%
60/68 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.6%
14/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.9%
2/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.6%
14/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.6%
29/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
34/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
32.4%
22/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
45.6%
31/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.4%
3/68 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
54.4%
37/68 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.4%
3/68 • 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: STEROID INDUCED DIABETES
|
1.5%
1/68 • 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: VITAMIN B12 DEFICIENCY
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.1%
30/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.4%
3/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
8/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.8%
8/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.4%
5/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: ADHESIVE CAPSULITIS
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: BILATERAL LEG CRAMPING
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: CALF CRAMPS
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: HARD BONY SWELLING ON LEFT HEEL
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Other, specify: INTERMITTENT PAIN IN R GROIN & CALF
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Other, specify: L SHOULDER PARTIAL THICKNESS TEAR, BURSITIS
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: MUSCLE INJURY
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Other, specify: PAIN FROM HISTORICAL SPORTS INJURIES IN EXTREMITIES
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: STEROID MYOPATHY
|
1.5%
1/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.2%
9/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.4%
3/68 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
4/68 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.9%
4/68 • 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Concentration impairment
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Dizziness
|
8.8%
6/68 • 5 years
|
|
Nervous system disorders
Dysarthria
|
11.8%
8/68 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
27.9%
19/68 • 5 years
|
|
Nervous system disorders
Dysphasia
|
25.0%
17/68 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.9%
4/68 • 5 years
|
|
Nervous system disorders
Headache
|
63.2%
43/68 • 5 years
|
|
Nervous system disorders
Hypersomnia
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Lethargy
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Memory impairment
|
39.7%
27/68 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify: ANOMIA
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify: DYSMETRIA
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify: GAIT UNSTEADINESS
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify: PERIPHERAL NERVE COMPRESSION - R FOOT
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Neuralgia
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Paresthesia
|
20.6%
14/68 • 5 years
|
|
Nervous system disorders
Pyramidal tract syndrome
|
25.0%
17/68 • 5 years
|
|
Nervous system disorders
Radiculitis
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Seizure
|
45.6%
31/68 • 5 years
|
|
Nervous system disorders
Sinus pain
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Somnolence
|
1.5%
1/68 • 5 years
|
|
Nervous system disorders
Stroke
|
2.9%
2/68 • 5 years
|
|
Nervous system disorders
Tremor
|
10.3%
7/68 • 5 years
|
|
Psychiatric disorders
Agitation
|
2.9%
2/68 • 5 years
|
|
Psychiatric disorders
Anxiety
|
8.8%
6/68 • 5 years
|
|
Psychiatric disorders
Confusion
|
11.8%
8/68 • 5 years
|
|
Psychiatric disorders
Depression
|
11.8%
8/68 • 5 years
|
|
Psychiatric disorders
Hallucinations
|
2.9%
2/68 • 5 years
|
|
Psychiatric disorders
Insomnia
|
16.2%
11/68 • 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.5%
1/68 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
7.4%
5/68 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
67.6%
46/68 • 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: BLADDER PRESSURE
|
1.5%
1/68 • 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: BLADDER SPASMS
|
1.5%
1/68 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
4.4%
3/68 • 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
13.2%
9/68 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
2/68 • 5 years
|
|
Renal and urinary disorders
Urinary tract pain
|
1.5%
1/68 • 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
2.9%
2/68 • 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
1.5%
1/68 • 5 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.5%
1/68 • 5 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.5%
1/68 • 5 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: ABNORMAL PAP SMEAR
|
1.5%
1/68 • 5 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: ATYPICAL DUCTAL HYPERPLASIA - LEFT BREAST
|
1.5%
1/68 • 5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.5%
1/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.4%
3/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.5%
1/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.1%
15/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.8%
6/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
29.4%
20/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
2/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
19.1%
13/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.8%
8/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
75.0%
51/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
1/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.8%
8/68 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.9%
2/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.3%
24/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.1%
13/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
2/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
3/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.8%
8/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.1%
13/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: BASAL CELL CARCINOMA REMOVAL
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: BILATERAL FOREARMS BRUISING, INTERMITTENT
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: BIOPSY OF SCAB IN SITU LEFT NOSE
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: CALLOUS PATCHES BILATERAL FEET
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: CALLUS-LIKE FORMATION ON FOOT SKIN GRAFTS
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: DELAYED WOUND HEALING; AVASTIN
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: ECZEMATOUS DERMATITIS L FOREARM
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: HIVES ON R FLANK - DUE TO STRESS
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: HIVES/RASH
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: HYPERPIGMENTED SKIN LESIONS; CARBOPLATIN
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: I&D OF MID-BACK BOIL
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: LACERATION REQUIRING SUTURES
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: LEFT LE SKIN LESION S/P PUNCH BIOPSY
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Other, specify: MILD ERYTHEMA AROUND THE RIGHT BACKSIDE WITH QUESTIONING RESOLVING IMPETIGO.
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: MULTIPLE ABRASIONS FROM FALL
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: NON-INFECTED INGROWN TOENAIL
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: PETECHIAE B/L THIGHS; AVASTIN
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: PIMPLE/BUG BITE
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: R AND L PLANTAR CALLUSES
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Other, specify: R HAND SMALL SKIN TEAR; SECONDARY TO LONG TERM STEROID USE
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: REDNESS FROM TICK BITE
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Other, specify: REDNESS/FLUSHING OF FACE; POSSIBLY DUE TO STEROIDS
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: SCALP FOLLICULITIS
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: SKIN TEAR/BRUISING LEFT ELBOW
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: SQUAMOUS CELL CARCINOMA ON NOSE
|
1.5%
1/68 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.5%
1/68 • 5 years
|
|
Vascular disorders
Hematoma
|
1.5%
1/68 • 5 years
|
|
Vascular disorders
Hot flashes
|
1.5%
1/68 • 5 years
|
|
Vascular disorders
Hypertension
|
57.4%
39/68 • 5 years
|
|
Vascular disorders
Hypotension
|
4.4%
3/68 • 5 years
|
|
Vascular disorders
Phlebitis
|
1.5%
1/68 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
10.3%
7/68 • 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify: BILATERAL LE CLAUDICATION
|
1.5%
1/68 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place