Trial Outcomes & Findings for Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma (NCT NCT00268203)
NCT ID: NCT00268203
Last Updated: 2017-01-09
Results Overview
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter \[SPPD\] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
765 participants
Primary outcome timeframe
From randomization until the first documented complete response or partial response (up to 161 months)
Results posted on
2017-01-09
Participant Flow
NHL=Non-Hodgkin's Lymphoma.
Participant milestones
| Measure |
Tositumomab and Iodine I-131 Tositumomab
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Overall Study
STARTED
|
765
|
|
Overall Study
Completed 2 Years of Follow-up
|
62
|
|
Overall Study
COMPLETED
|
118
|
|
Overall Study
NOT COMPLETED
|
647
|
Reasons for withdrawal
| Measure |
Tositumomab and Iodine I-131 Tositumomab
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
92
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Received Other NHL Therapy
|
7
|
|
Overall Study
Progressive Disease
|
359
|
|
Overall Study
Death
|
84
|
|
Overall Study
Reason Not Specified
|
34
|
|
Overall Study
Completed 2 Years of Follow-up
|
62
|
Baseline Characteristics
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=765 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Gender
Female
|
354 Participants
n=5 Participants
|
|
Gender
Male
|
411 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
711 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Portuguese
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Iranian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arab
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Peruvian
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until the first documented complete response or partial response (up to 161 months)Population: Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed.
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter \[SPPD\] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=746 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
CR or PR
|
437 Participants
|
|
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
CR
|
238 Participants
|
PRIMARY outcome
Timeframe: From randomization until the first documented complete response or partial response (up to 161 months)Population: Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed.
A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter \[SPPD\] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=502 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
CR or PR
|
339 Participants
|
|
Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
CR
|
196 Participants
|
PRIMARY outcome
Timeframe: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)Population: ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=437 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Duration of Response for Participants With Unconfirmed Response (CR+PR)
|
21.0 Months
Interval 17.3 to
The upper limit of the confidence interval could not be calculated because there were too few events of progression.
|
PRIMARY outcome
Timeframe: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)Population: ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.
Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=339 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Duration of Response for Participants With Confirmed Response (CR+PR)
|
NA Months
A median cannot be calculated because the survival distribution from the Kaplan-Meier survival curve does not reach 50%.
|
PRIMARY outcome
Timeframe: From the time of the first documented unconfirmed CR until PD (up to 161 months)Population: ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.
DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=238 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Duration of Response (DOR) in Unconfirmed Complete Responders
|
NA Months
A median cannot be calculated because the survival distribution from the Kaplan-Meier survival curve does not reach 50%.
|
PRIMARY outcome
Timeframe: From the time of the first documented CR until PD (up to 161 months)Population: ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.
DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=196 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Duration of Response (DOR) in Confirmed Complete Responders
|
NA Months
A median cannot be calculated because the survival distribution from the Kaplan-Meier survival curve does not reach 50%.
|
PRIMARY outcome
Timeframe: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)Population: ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact.
Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=765 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Time to Progression or Death
|
9.2 Months
Interval 6.8 to 10.8
|
SECONDARY outcome
Timeframe: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)Population: ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact.
Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.
Outcome measures
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=765 Participants
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Time to Treatment Failure
|
9.0 Months
Interval 6.3 to 10.4
|
Adverse Events
Tositumomab and Iodine I-131 Tositumomab
Serious events: 204 serious events
Other events: 650 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=765 participants at risk
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
4.4%
34/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
2.4%
18/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.65%
5/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.65%
5/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.52%
4/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.39%
3/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to breast
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of skin
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasi
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.13%
1/765
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
16/765
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
16/765
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
10/765
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
9/765
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
9/765
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.65%
5/765
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.13%
1/765
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.13%
1/765
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.13%
1/765
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.13%
1/765
|
|
Infections and infestations
Pneumonia
|
1.0%
8/765
|
|
Infections and infestations
Sepsis
|
1.0%
8/765
|
|
Infections and infestations
Cellulitis
|
0.52%
4/765
|
|
Infections and infestations
Abdominal abscess
|
0.13%
1/765
|
|
Infections and infestations
Bronchitis
|
0.13%
1/765
|
|
Infections and infestations
Cellulitis orbital
|
0.13%
1/765
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
1/765
|
|
Infections and infestations
Device related sepsis
|
0.13%
1/765
|
|
Infections and infestations
Herpes zoster
|
0.13%
1/765
|
|
Infections and infestations
Infection
|
0.13%
1/765
|
|
Infections and infestations
Kidney infection
|
0.13%
1/765
|
|
Infections and infestations
Neutropenic sepsis
|
0.13%
1/765
|
|
Infections and infestations
Peritoneal abscess
|
0.13%
1/765
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.13%
1/765
|
|
Infections and infestations
Pseudomonal sepsis
|
0.13%
1/765
|
|
Infections and infestations
Skin bacterial infection
|
0.13%
1/765
|
|
Infections and infestations
Staphylococcal sepsis
|
0.13%
1/765
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/765
|
|
Infections and infestations
Urosepsis
|
0.13%
1/765
|
|
General disorders
Pyrexia
|
2.5%
19/765
|
|
General disorders
Chills
|
0.78%
6/765
|
|
General disorders
Asthenia
|
0.39%
3/765
|
|
General disorders
Fatigue
|
0.39%
3/765
|
|
General disorders
Pain
|
0.39%
3/765
|
|
General disorders
Chest pain
|
0.26%
2/765
|
|
General disorders
Oedema peripheral
|
0.26%
2/765
|
|
General disorders
Generalised oedema
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
10/765
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
6/765
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.52%
4/765
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.39%
3/765
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.13%
1/765
|
|
Gastrointestinal disorders
Nausea
|
0.78%
6/765
|
|
Gastrointestinal disorders
Vomiting
|
0.78%
6/765
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
3/765
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
3/765
|
|
Gastrointestinal disorders
Constipation
|
0.26%
2/765
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.26%
2/765
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.13%
1/765
|
|
Gastrointestinal disorders
Abdominal wall mass
|
0.13%
1/765
|
|
Gastrointestinal disorders
Ascites
|
0.13%
1/765
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/765
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.13%
1/765
|
|
Gastrointestinal disorders
Odynophagia
|
0.13%
1/765
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.13%
1/765
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
1/765
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
9/765
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.65%
5/765
|
|
Metabolism and nutrition disorders
Cachexia
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
6/765
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.65%
5/765
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.13%
1/765
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
2/765
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
2/765
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.26%
2/765
|
|
Cardiac disorders
Tachycardia
|
0.26%
2/765
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/765
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
1/765
|
|
Cardiac disorders
Left ventricular failure
|
0.13%
1/765
|
|
Cardiac disorders
Pericardial effusion
|
0.13%
1/765
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/765
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
1/765
|
|
Nervous system disorders
Spinal cord compression
|
0.26%
2/765
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/765
|
|
Nervous system disorders
Convulsion
|
0.13%
1/765
|
|
Nervous system disorders
Depressed level of consciousness
|
0.13%
1/765
|
|
Nervous system disorders
Lethargy
|
0.13%
1/765
|
|
Nervous system disorders
Paralysis
|
0.13%
1/765
|
|
Nervous system disorders
Syncope
|
0.13%
1/765
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
1/765
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.13%
1/765
|
|
Renal and urinary disorders
Renal failure acute
|
0.39%
3/765
|
|
Renal and urinary disorders
Renal failure
|
0.26%
2/765
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.26%
2/765
|
|
Renal and urinary disorders
Dysuria
|
0.13%
1/765
|
|
Psychiatric disorders
Confusional state
|
0.39%
3/765
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.13%
1/765
|
|
Psychiatric disorders
Mental status changes
|
0.13%
1/765
|
|
Investigations
Neutrophil count decreased
|
0.26%
2/765
|
|
Investigations
Clostridium test positive
|
0.13%
1/765
|
|
Investigations
Haemoglobin decreased
|
0.13%
1/765
|
|
Investigations
Weight decreased
|
0.13%
1/765
|
|
Vascular disorders
Hypotension
|
0.26%
2/765
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/765
|
|
Vascular disorders
Haemorrhage
|
0.13%
1/765
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.13%
1/765
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.13%
1/765
|
|
Endocrine disorders
Hyperthyroidism
|
0.13%
1/765
|
|
Immune system disorders
Serum sickness
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.13%
1/765
|
Other adverse events
| Measure |
Tositumomab and Iodine I-131 Tositumomab
n=765 participants at risk
Participants were treated with a saturated solution of potassium iodide (KI), Lugol's solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
|
|---|---|
|
Investigations
Absolute neutrophil count < 1000 cells/mm^3
|
38.3%
293/765
|
|
Investigations
Platelets < 50000 cells/mm^3
|
36.3%
278/765
|
|
Investigations
White blood cells < 2000 cells/mm^3
|
34.0%
260/765
|
|
Investigations
Hemoglobin < 8.0 grams per deciliter
|
11.9%
91/765
|
|
General disorders
Fatigue
|
21.7%
166/765
|
|
General disorders
Pyrexia
|
10.7%
82/765
|
|
General disorders
Chills
|
7.5%
57/765
|
|
General disorders
Oedema peripheral
|
3.0%
23/765
|
|
General disorders
Pain
|
2.5%
19/765
|
|
General disorders
Asthenia
|
1.7%
13/765
|
|
General disorders
Influenza like illness
|
1.7%
13/765
|
|
General disorders
Chest pain
|
1.6%
12/765
|
|
General disorders
Chest discomfort
|
1.4%
11/765
|
|
General disorders
Malaise
|
0.78%
6/765
|
|
General disorders
Feeling hot
|
0.65%
5/765
|
|
General disorders
Axillary pain
|
0.26%
2/765
|
|
General disorders
Discomfort
|
0.26%
2/765
|
|
General disorders
Face oedema
|
0.26%
2/765
|
|
General disorders
Feeling cold
|
0.26%
2/765
|
|
General disorders
Local swelling
|
0.26%
2/765
|
|
General disorders
Oedema
|
0.26%
2/765
|
|
General disorders
Crepitations
|
0.13%
1/765
|
|
General disorders
Feeling abnormal
|
0.13%
1/765
|
|
General disorders
Infusion site pain
|
0.13%
1/765
|
|
General disorders
Infusion site pruritus
|
0.13%
1/765
|
|
General disorders
Injection site haematoma
|
0.13%
1/765
|
|
General disorders
Local reaction
|
0.13%
1/765
|
|
General disorders
Mucosal inflammation
|
0.13%
1/765
|
|
General disorders
Sensation of foreign body
|
0.13%
1/765
|
|
General disorders
Spinal pain
|
0.13%
1/765
|
|
General disorders
Thirst
|
0.13%
1/765
|
|
Gastrointestinal disorders
Nausea
|
17.6%
135/765
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
52/765
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
49/765
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
26/765
|
|
Gastrointestinal disorders
Constipation
|
2.2%
17/765
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
12/765
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
12/765
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
9/765
|
|
Gastrointestinal disorders
Dyspepsia
|
0.92%
7/765
|
|
Gastrointestinal disorders
Dysphagia
|
0.78%
6/765
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
5/765
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.52%
4/765
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.52%
4/765
|
|
Gastrointestinal disorders
Dry mouth
|
0.39%
3/765
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.39%
3/765
|
|
Gastrointestinal disorders
Melaena
|
0.39%
3/765
|
|
Gastrointestinal disorders
Oral pain
|
0.39%
3/765
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
3/765
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.26%
2/765
|
|
Gastrointestinal disorders
Flatulence
|
0.26%
2/765
|
|
Gastrointestinal disorders
Haematochezia
|
0.26%
2/765
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.26%
2/765
|
|
Gastrointestinal disorders
Oedema mouth
|
0.26%
2/765
|
|
Gastrointestinal disorders
Toothache
|
0.26%
2/765
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.26%
2/765
|
|
Gastrointestinal disorders
Ascites
|
0.13%
1/765
|
|
Gastrointestinal disorders
Cheilitis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Faces discoloured
|
0.13%
1/765
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.13%
1/765
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.13%
1/765
|
|
Gastrointestinal disorders
Gingival pain
|
0.13%
1/765
|
|
Gastrointestinal disorders
Glossodynia
|
0.13%
1/765
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.13%
1/765
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.13%
1/765
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/765
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.13%
1/765
|
|
Gastrointestinal disorders
Lip dry
|
0.13%
1/765
|
|
Gastrointestinal disorders
Lip pain
|
0.13%
1/765
|
|
Gastrointestinal disorders
Lip swelling
|
0.13%
1/765
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
1/765
|
|
Gastrointestinal disorders
Oral disorder
|
0.13%
1/765
|
|
Gastrointestinal disorders
Oral pruritus
|
0.13%
1/765
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.13%
1/765
|
|
Gastrointestinal disorders
Regurgitation
|
0.13%
1/765
|
|
Gastrointestinal disorders
Tongue disorder
|
0.13%
1/765
|
|
Blood and lymphatic system disorders
Anaemia
|
12.7%
97/765
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.8%
60/765
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
51/765
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.2%
9/765
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.92%
7/765
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.78%
6/765
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.52%
4/765
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.52%
4/765
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.52%
4/765
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.26%
2/765
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Priritus
|
5.9%
45/765
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
37/765
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
22/765
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
20/765
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.2%
17/765
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
9/765
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.52%
4/765
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.52%
4/765
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.39%
3/765
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.39%
3/765
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.39%
3/765
|
|
Skin and subcutaneous tissue disorders
Skin efoliation
|
0.39%
3/765
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.26%
2/765
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.13%
1/765
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
55/765
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
39/765
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
25/765
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
15/765
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
9/765
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.92%
7/765
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.92%
7/765
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.78%
6/765
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.65%
5/765
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.52%
4/765
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.52%
4/765
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.39%
3/765
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.26%
2/765
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.13%
1/765
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
41/765
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
39/765
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
17/765
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
14/765
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
8/765
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
8/765
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
7/765
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.92%
7/765
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.78%
6/765
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.78%
6/765
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.52%
4/765
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.52%
4/765
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.39%
3/765
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.39%
3/765
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.39%
3/765
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.39%
3/765
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.26%
2/765
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.13%
1/765
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.13%
1/765
|
|
Nervous system disorders
Headache
|
6.9%
53/765
|
|
Nervous system disorders
Dizziness
|
4.4%
34/765
|
|
Nervous system disorders
Somnolence
|
2.0%
15/765
|
|
Nervous system disorders
Dysgeusia
|
1.4%
11/765
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
11/765
|
|
Nervous system disorders
Paraesthesia
|
0.78%
6/765
|
|
Nervous system disorders
Burning sensation
|
0.39%
3/765
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.39%
3/765
|
|
Nervous system disorders
Lethargy
|
0.26%
2/765
|
|
Nervous system disorders
Migraine
|
0.26%
2/765
|
|
Nervous system disorders
Syncope
|
0.26%
2/765
|
|
Nervous system disorders
Akathisia
|
0.13%
1/765
|
|
Nervous system disorders
Aphonia
|
0.13%
1/765
|
|
Nervous system disorders
Balance disorder
|
0.13%
1/765
|
|
Nervous system disorders
Dysarthria
|
0.13%
1/765
|
|
Nervous system disorders
Loss of consciousness
|
0.13%
1/765
|
|
Nervous system disorders
Memory impairment
|
0.13%
1/765
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.13%
1/765
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.13%
1/765
|
|
Nervous system disorders
Restless legs syndrome
|
0.13%
1/765
|
|
Nervous system disorders
Sciatica
|
0.13%
1/765
|
|
Nervous system disorders
Sensory loss
|
0.13%
1/765
|
|
Nervous system disorders
Sinus headache
|
0.13%
1/765
|
|
Nervous system disorders
Tremor
|
0.13%
1/765
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.13%
1/765
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
20/765
|
|
Infections and infestations
Sinusitis
|
1.8%
14/765
|
|
Infections and infestations
Pneumonia
|
1.7%
13/765
|
|
Infections and infestations
Herpes zoster
|
1.3%
10/765
|
|
Infections and infestations
Urinary tract infection
|
1.0%
8/765
|
|
Infections and infestations
Oral herpes
|
0.78%
6/765
|
|
Infections and infestations
Influenza
|
0.65%
5/765
|
|
Infections and infestations
Nasopharyngitis
|
0.65%
5/765
|
|
Infections and infestations
Rhinitis
|
0.52%
4/765
|
|
Infections and infestations
Bronchitis
|
0.39%
3/765
|
|
Infections and infestations
Cellulitis
|
0.39%
3/765
|
|
Infections and infestations
Herpes virus infection
|
0.26%
2/765
|
|
Infections and infestations
Oral candidiasis
|
0.26%
2/765
|
|
Infections and infestations
Otitis media
|
0.26%
2/765
|
|
Infections and infestations
Tooth abscess
|
0.26%
2/765
|
|
Infections and infestations
Tooth infection
|
0.26%
2/765
|
|
Infections and infestations
Vaginal infection
|
0.26%
2/765
|
|
Infections and infestations
Wound infection
|
0.26%
2/765
|
|
Infections and infestations
Abscess oral
|
0.13%
1/765
|
|
Infections and infestations
Bronchitis viral
|
0.13%
1/765
|
|
Infections and infestations
Candidiasis
|
0.13%
1/765
|
|
Infections and infestations
Chronic sinusitis
|
0.13%
1/765
|
|
Infections and infestations
Conjunctivitis infective
|
0.13%
1/765
|
|
Infections and infestations
Ear infection
|
0.13%
1/765
|
|
Infections and infestations
Genital herpes
|
0.13%
1/765
|
|
Infections and infestations
Herpes simplex
|
0.13%
1/765
|
|
Infections and infestations
Hordeolum
|
0.13%
1/765
|
|
Infections and infestations
Infection
|
0.13%
1/765
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
1/765
|
|
Infections and infestations
Paronychia
|
0.13%
1/765
|
|
Infections and infestations
Parotitis
|
0.13%
1/765
|
|
Infections and infestations
Pharyngitis
|
0.13%
1/765
|
|
Infections and infestations
Varicella
|
0.13%
1/765
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.13%
1/765
|
|
Investigations
Haemoglobin decreased
|
2.5%
19/765
|
|
Investigations
Weight decreased
|
1.7%
13/765
|
|
Investigations
Platelet count decreased
|
1.0%
8/765
|
|
Investigations
White blood cell count decreased
|
0.78%
6/765
|
|
Investigations
Blood pressure systolic decreased
|
0.52%
4/765
|
|
Investigations
Body temperature increased
|
0.52%
4/765
|
|
Investigations
Neutrophil count decreased
|
0.39%
3/765
|
|
Investigations
Blood creatinine increased
|
0.26%
2/765
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.26%
2/765
|
|
Investigations
Haematocrit decreased
|
0.26%
2/765
|
|
Investigations
Red blood cell count decreased
|
0.26%
2/765
|
|
Investigations
Band neutrophil count decreased
|
0.13%
1/765
|
|
Investigations
Blood pressure increased
|
0.13%
1/765
|
|
Investigations
Blood test abnormal
|
0.13%
1/765
|
|
Investigations
Electroencephalogram abnormal
|
0.13%
1/765
|
|
Investigations
Heart rate irregular
|
0.13%
1/765
|
|
Investigations
Prostatic specific antigen increased
|
0.13%
1/765
|
|
Investigations
Urine output decreased
|
0.13%
1/765
|
|
Investigations
Urine output increased
|
0.13%
1/765
|
|
Endocrine disorders
Hypothyroidism
|
5.8%
44/765
|
|
Endocrine disorders
Goitre
|
0.26%
2/765
|
|
Endocrine disorders
Hyperthyroidism
|
0.26%
2/765
|
|
Endocrine disorders
Thyroid disorder
|
0.26%
2/765
|
|
Endocrine disorders
Thyroid pain
|
0.13%
1/765
|
|
Endocrine disorders
Thyroiditis
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
36/765
|
|
Metabolism and nutrition disorders
Dehydration
|
0.78%
6/765
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.52%
4/765
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.39%
3/765
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.26%
2/765
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.26%
2/765
|
|
Metabolism and nutrition disorders
Cachexia
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
1/765
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.13%
1/765
|
|
Vascular disorders
Hypotension
|
2.1%
16/765
|
|
Vascular disorders
Flushing
|
1.4%
11/765
|
|
Vascular disorders
Hypertension
|
0.65%
5/765
|
|
Vascular disorders
Hot flush
|
0.39%
3/765
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
2/765
|
|
Vascular disorders
Pallor
|
0.26%
2/765
|
|
Vascular disorders
Peripheral coldness
|
0.26%
2/765
|
|
Vascular disorders
Haemorrhage
|
0.13%
1/765
|
|
Vascular disorders
Orthostatic hypotension
|
0.13%
1/765
|
|
Vascular disorders
Phlebitis
|
0.13%
1/765
|
|
Psychiatric disorders
Insomnia
|
1.3%
10/765
|
|
Psychiatric disorders
Confusional state
|
0.92%
7/765
|
|
Psychiatric disorders
Depression
|
0.78%
6/765
|
|
Psychiatric disorders
Anxiety
|
0.52%
4/765
|
|
Psychiatric disorders
Disorientation
|
0.13%
1/765
|
|
Psychiatric disorders
Panic attack
|
0.13%
1/765
|
|
Eye disorders
Diplopia
|
0.52%
4/765
|
|
Eye disorders
Vision blurred
|
0.52%
4/765
|
|
Eye disorders
Eye pain
|
0.39%
3/765
|
|
Eye disorders
Ocular hyperaemia
|
0.39%
3/765
|
|
Eye disorders
Photophobia
|
0.39%
3/765
|
|
Eye disorders
Conjunctivitis
|
0.26%
2/765
|
|
Eye disorders
Eye pruritus
|
0.26%
2/765
|
|
Eye disorders
Eye swelling
|
0.26%
2/765
|
|
Eye disorders
Eyelid oedema
|
0.26%
2/765
|
|
Eye disorders
Lacrimation increased
|
0.26%
2/765
|
|
Eye disorders
Visual impairment
|
0.26%
2/765
|
|
Eye disorders
Abnormal sensation in eye
|
0.13%
1/765
|
|
Eye disorders
Dark circles under eyes
|
0.13%
1/765
|
|
Eye disorders
Eye irritation
|
0.13%
1/765
|
|
Eye disorders
Eyelid ptosis
|
0.13%
1/765
|
|
Eye disorders
Vitreous floaters
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
9/765
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.26%
2/765
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Tracheal deviation
|
0.13%
1/765
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.52%
4/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.39%
3/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma transformation
|
0.26%
2/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.13%
1/765
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.13%
1/765
|
|
Renal and urinary disorders
Pollakiuria
|
0.52%
4/765
|
|
Renal and urinary disorders
Renal failure
|
0.39%
3/765
|
|
Renal and urinary disorders
Dysuria
|
0.26%
2/765
|
|
Renal and urinary disorders
Bladder discomfort
|
0.13%
1/765
|
|
Renal and urinary disorders
Bladder spasm
|
0.13%
1/765
|
|
Renal and urinary disorders
Haematuria
|
0.13%
1/765
|
|
Renal and urinary disorders
Hydronephrosis
|
0.13%
1/765
|
|
Renal and urinary disorders
Micturition urgency
|
0.13%
1/765
|
|
Renal and urinary disorders
Nocturia
|
0.13%
1/765
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.13%
1/765
|
|
Renal and urinary disorders
Urinary incontinence
|
0.13%
1/765
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.39%
3/765
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.26%
2/765
|
|
Reproductive system and breast disorders
Breast induration
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Genital rash
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Testicular pain
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.13%
1/765
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.13%
1/765
|
|
Cardiac disorders
Tachycardia
|
0.52%
4/765
|
|
Cardiac disorders
Palpitation
|
0.26%
2/765
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.26%
2/765
|
|
Cardiac disorders
Arrthythmia
|
0.13%
1/765
|
|
Cardiac disorders
Bradycardia
|
0.13%
1/765
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
1/765
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.13%
1/765
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/765
|
|
Cardiac disorders
Sinus tachycardia
|
0.13%
1/765
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
1/765
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.26%
2/765
|
|
Ear and labyrinth disorders
Tinnitus
|
0.26%
2/765
|
|
Ear and labyrinth disorders
Ear congestion
|
0.13%
1/765
|
|
Ear and labyrinth disorders
Ear pain
|
0.13%
1/765
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.13%
1/765
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.13%
1/765
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/765
|
|
Immune system disorders
Hypersensitivity
|
0.52%
4/765
|
|
Immune system disorders
Anaphylactoid reaction
|
0.26%
2/765
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.13%
1/765
|
|
Surgical and medical procedures
Thyroid therapy
|
0.13%
1/765
|
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