Trial Outcomes & Findings for Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody (NCT NCT00938041)
NCT ID: NCT00938041
Last Updated: 2017-01-09
Results Overview
Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Results posted on
2017-01-09
Participant Flow
Participant milestones
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Received Alternative Therapy
|
1
|
|
Overall Study
Progressive Disease
|
5
|
|
Overall Study
Death
|
12
|
|
Overall Study
Adrenal Insufficiency
|
3
|
Baseline Characteristics
Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody
Baseline characteristics by cohort
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population: all participants who received at least one dose of study drug
Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Number of Participants With Complete Response and Confirmed Complete Response
Complete response
|
8 Participants
|
|
Number of Participants With Complete Response and Confirmed Complete Response
Confirmed complete response
|
8 Participants
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.
For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion \<=2 centimeters (cm) in diameter by radiographic evaluation or \<=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=18 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Duration of Response for All Confirmed Responders (CR + CCR + PR)
|
18.9 Months
Interval 10.4 to 94.3
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.
Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Progression-free Survival
|
11.9 Months
Interval 6.3 to 26.5
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.
Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Time to Treatment Failure
|
11.7 Months
Interval 6.0 to 21.4
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study.
Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Overall Survival
|
64.2 Months
Interval 52.5 to 159.0
|
PRIMARY outcome
Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)Population: ITT-Exposed Population
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.
Outcome measures
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)
Any Adverse Event
|
32 Participants
|
|
Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)
Any Serious Adverse Event
|
18 Participants
|
Adverse Events
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
Serious events: 18 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 participants at risk
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
15.6%
5/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
9.4%
3/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.1%
1/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
3.1%
1/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
3.1%
1/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32
|
|
Gastrointestinal disorders
Caecitis
|
3.1%
1/32
|
|
Infections and infestations
Lobar pneumonia
|
3.1%
1/32
|
|
Infections and infestations
Pseudomonal sepsis
|
3.1%
1/32
|
|
Infections and infestations
Rash pustular
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Lymphomatoid papulosis
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
1/32
|
|
Endocrine disorders
Adrenal insufficiency
|
3.1%
1/32
|
|
Immune system disorders
Anaphylactic reaction
|
3.1%
1/32
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32
|
|
Vascular disorders
Hypotension
|
3.1%
1/32
|
Other adverse events
| Measure |
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab
n=32 participants at risk
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7-14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
General disorders
Fatigue
|
46.9%
15/32
|
|
General disorders
Asthenia
|
18.8%
6/32
|
|
General disorders
Chills
|
12.5%
4/32
|
|
General disorders
Oedema peripheral
|
12.5%
4/32
|
|
General disorders
Pyrexia
|
9.4%
3/32
|
|
General disorders
Pain
|
6.2%
2/32
|
|
General disorders
Axillary pain
|
3.1%
1/32
|
|
General disorders
Chest discomfort
|
3.1%
1/32
|
|
General disorders
Local swelling
|
3.1%
1/32
|
|
Gastrointestinal disorders
Nausea
|
43.8%
14/32
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
2/32
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.1%
1/32
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
1/32
|
|
Gastrointestinal disorders
Epigastric discomfort
|
3.1%
1/32
|
|
Gastrointestinal disorders
Faecal incontinence
|
3.1%
1/32
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.1%
1/32
|
|
Gastrointestinal disorders
Tongue eruption
|
3.1%
1/32
|
|
Investigations
White blood cell < 2000 cells/mm^3
|
43.8%
14/32
|
|
Investigations
Absolute neutrophil count < 1000 cells/mm^3
|
37.5%
12/32
|
|
Investigations
Platelets < 50000 cells/mm^3
|
37.5%
12/32
|
|
Investigations
Hemoglobin < 8.0 grams/deciliter
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
4/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
5/32
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
1/32
|
|
Infections and infestations
Oral herpes
|
9.4%
3/32
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32
|
|
Infections and infestations
Infection
|
3.1%
1/32
|
|
Infections and infestations
Lower respiratory tract infection
|
3.1%
1/32
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32
|
|
Nervous system disorders
Headache
|
18.8%
6/32
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
2/32
|
|
Nervous system disorders
Somnolence
|
6.2%
2/32
|
|
Nervous system disorders
Mental impairment
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
4/32
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
1/32
|
|
Endocrine disorders
Hypothyroidism
|
18.8%
6/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
3/32
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32
|
|
Vascular disorders
Hypotension
|
6.2%
2/32
|
|
Vascular disorders
Lymphoedema
|
3.1%
1/32
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
1/32
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
1/32
|
|
Injury, poisoning and procedural complications
Laceration
|
3.1%
1/32
|
|
Injury, poisoning and procedural complications
Wound
|
3.1%
1/32
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.2%
2/32
|
|
Investigations
Breath sounds abnormal
|
3.1%
1/32
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32
|
|
Psychiatric disorders
Confusional state
|
3.1%
1/32
|
|
Psychiatric disorders
Depression
|
3.1%
1/32
|
|
Psychiatric disorders
Disorientation
|
3.1%
1/32
|
|
Eye disorders
Diplopia
|
3.1%
1/32
|
|
Eye disorders
Pupillary reflex impaired
|
3.1%
1/32
|
|
Eye disorders
Strabismus
|
3.1%
1/32
|
|
Renal and urinary disorders
Dysuria
|
6.2%
2/32
|
|
Renal and urinary disorders
Stress urinary incontinence
|
3.1%
1/32
|
|
Cardiac disorders
Tachycardia
|
3.1%
1/32
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.1%
1/32
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER