Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors (NCT NCT01841736)
NCT ID: NCT01841736
Last Updated: 2025-11-28
Results Overview
PFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
171 participants
Primary outcome timeframe
From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
Arm I (Pazopanib Hydrochloride)
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
74
|
|
Overall Study
Crossover
|
0
|
49
|
|
Overall Study
COMPLETED
|
97
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
Baseline characteristics by cohort
| Measure |
Arm I (Pazopanib Hydrochloride)
n=97 Participants
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
n=74 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=30 Participants
|
63 years
n=30 Participants
|
63 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=30 Participants
|
33 Participants
n=30 Participants
|
96 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=30 Participants
|
41 Participants
n=30 Participants
|
75 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race (White vs Non-White) · Non-White
|
20 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
32 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race (White vs Non-White) · White
|
77 Participants
n=30 Participants
|
62 Participants
n=30 Participants
|
139 Participants
n=60 Participants
|
|
ECOG Performance status
0
|
48 Participants
n=30 Participants
|
41 Participants
n=30 Participants
|
89 Participants
n=60 Participants
|
|
ECOG Performance status
1
|
48 Participants
n=30 Participants
|
33 Participants
n=30 Participants
|
81 Participants
n=60 Participants
|
|
ECOG Performance status
missing data
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 yearsPFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Outcome measures
| Measure |
Arm II (Placebo)
n=74 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=97 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
8.5 months
Interval 5.8 to 8.9
|
11.6 months
Interval 11.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Per protocol, patients who crossover from placebo to active therapy at the time of progression will be followed for a second progression unless they withdraw from treatment for other reasons; in that case they will be followed for toxicity and survival only; thus response data are not available for "Placebo Crossover" group.
The best response per RECIST 1.1 criteria of participants receiving randomized treatment assignment. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites, Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. Progressive disease (PD): Any new lesion or increase by ≥20% of previously involved sites from nadir. Note that those considered evaluable for best response here were those who had disease measurements while on treatment. Those who discontinued therapy early prior to a disease evaluation were not included.
Outcome measures
| Measure |
Arm II (Placebo)
n=74 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=97 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Best Response
Partial Response
|
0 Participants
|
2 Participants
|
|
Best Response
Stable Disease
|
54 Participants
|
70 Participants
|
|
Best Response
Progressive Disease
|
14 Participants
|
4 Participants
|
|
Best Response
Not Evaluable
|
6 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From randomization until death from any cause, assessed up to 5 yearsPopulation: This trial only has two arms ((Arm I (pazopanib hydrochloride) and Arm II (placebo)) that were analyzed. Pazopanib hydrochloride and Pazopanib are synonyms and Pazopanib was deleted. Per protocol, OS will be estimated by the Kaplan-Meier method within each treatment arm. OS for placebo patients who crossed over is not a specified outcome measure.
Overall survival (OS) will be measured from randomization until death from any cause. A patient who is alive at the time of the statistical analysis will be considered censored at the last date of known contact. OS will be estimated by the Kaplan-Meier method within each treatment arm.
Outcome measures
| Measure |
Arm II (Placebo)
n=74 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=97 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Overall Survival
|
42.4 months
Interval 29.7 to 50.8
|
41.3 months
Interval 31.9 to 44.8
|
SECONDARY outcome
Timeframe: From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 yearsPopulation: Duration of Response won't be a viable analysis as there aren't enough patients with partial responses
Duration of response is defined as the time from documented response to time of progression and/or death. This time-to-event outcome will be summarized descriptively using the methods of Kaplan and Meier to characterize the cohort and distribution of this outcome.
Outcome measures
| Measure |
Arm II (Placebo)
n=1 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=3 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response
|
13.8 months
There aren't enough patients with partial responses
|
11.9 months
Interval 9.8 to
There aren't enough patients with partial responses
|
SECONDARY outcome
Timeframe: From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 yearsTime to treatment failure is defined as the time from randomization to the time that treatment is terminated, including the reasons of disease progression, adverse events, withdrawal from study, or death. This time-to-event outcome will be evaluated using the methods of Kaplan and Meier.
Outcome measures
| Measure |
Arm II (Placebo)
n=74 Participants
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=97 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Time to Treatment Failure
|
8.6 months
Interval 0.3 to 48.0
|
8.5 months
Interval 0.9 to 53.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsTime to second progression will be defined as the progression free survival from crossover re-registration to documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Outcome measures
| Measure |
Arm II (Placebo)
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=49 Participants
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
|---|---|---|
|
Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy
|
—
|
12.1 months
Interval 5.9 to 19.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 6 monthsKaplan-Meier methods will be used including calculations of 95% confidence intervals.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsBiochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline, and for 5-hydroxyindoleacetic acid \[5-HIAA\], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of serum chromogranin A (CGA) and 5-HIAA.
Outcome measures
Outcome data not reported
Adverse Events
Arm II (Placebo)
Serious events: 3 serious events
Other events: 71 other events
Deaths: 40 deaths
Placebo Crossover
Serious events: 2 serious events
Other events: 49 other events
Deaths: 29 deaths
Arm I (Pazopanib Hydrochloride)
Serious events: 16 serious events
Other events: 90 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Arm II (Placebo)
n=74 participants at risk
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=49 participants at risk
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
Arm I (Pazopanib Hydrochloride)
n=97 participants at risk
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
General disorders
Death NOS
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
10.3%
10/97 • Number of events 10 • Up to 5 years
|
|
General disorders
Sudden death NOS
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
4.1%
4/97 • Number of events 4 • Up to 5 years
|
Other adverse events
| Measure |
Arm II (Placebo)
n=74 participants at risk
Patients receive 800 mg placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
|
Placebo Crossover
n=49 participants at risk
Participants in Arm II (Placebo) who crossed over to receive pazopanib hydrochloride after having documented progression on Placebo.
|
Arm I (Pazopanib Hydrochloride)
n=97 participants at risk
Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 2 • Up to 5 years
|
3.1%
3/97 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 8 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 10 • Up to 5 years
|
1.0%
1/97 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/74 • Number of events 8 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
3.1%
3/97 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 14 • Up to 5 years
|
13.4%
13/97 • Number of events 154 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
4/74 • Number of events 9 • Up to 5 years
|
6.1%
3/49 • Number of events 6 • Up to 5 years
|
3.1%
3/97 • Number of events 13 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 15 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 24 • Up to 5 years
|
6.2%
6/97 • Number of events 27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
4/74 • Number of events 11 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
4.1%
4/97 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.1%
3/74 • Number of events 4 • Up to 5 years
|
6.1%
3/49 • Number of events 5 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
6.1%
3/49 • Number of events 17 • Up to 5 years
|
6.2%
6/97 • Number of events 26 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
10.8%
8/74 • Number of events 31 • Up to 5 years
|
16.3%
8/49 • Number of events 28 • Up to 5 years
|
21.6%
21/97 • Number of events 237 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 2 • Up to 5 years
|
2.1%
2/97 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 24 • Up to 5 years
|
3.1%
3/97 • Number of events 34 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Flushing
|
6.8%
5/74 • Number of events 23 • Up to 5 years
|
10.2%
5/49 • Number of events 22 • Up to 5 years
|
4.1%
4/97 • Number of events 12 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hot flashes
|
6.8%
5/74 • Number of events 35 • Up to 5 years
|
8.2%
4/49 • Number of events 15 • Up to 5 years
|
7.2%
7/97 • Number of events 25 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
62.2%
46/74 • Number of events 346 • Up to 5 years
|
71.4%
35/49 • Number of events 215 • Up to 5 years
|
70.1%
68/97 • Number of events 695 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.7%
2/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 6 • Up to 5 years
|
|
Cardiac disorders
Palpitations
|
1.4%
1/74 • Number of events 11 • Up to 5 years
|
4.1%
2/49 • Number of events 6 • Up to 5 years
|
1.0%
1/97 • Number of events 5 • Up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.7%
2/74 • Number of events 11 • Up to 5 years
|
4.1%
2/49 • Number of events 10 • Up to 5 years
|
3.1%
3/97 • Number of events 8 • Up to 5 years
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 13 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
3.1%
3/97 • Number of events 5 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.7%
2/74 • Number of events 38 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 10 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 3 • Up to 5 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 22 • Up to 5 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 3 • Up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 5 • Up to 5 years
|
5.2%
5/97 • Number of events 11 • Up to 5 years
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 7 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
2/74 • Number of events 3 • Up to 5 years
|
18.4%
9/49 • Number of events 13 • Up to 5 years
|
11.3%
11/97 • Number of events 55 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
4.1%
4/97 • Number of events 5 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
1.0%
1/97 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Floaters
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 3 • Up to 5 years
|
|
Eye disorders
Glaucoma
|
1.4%
1/74 • Number of events 3 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Eye disorders
Night blindness
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Periorbital edema
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 5 • Up to 5 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
4.1%
3/74 • Number of events 9 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
2.1%
2/97 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
27.0%
20/74 • Number of events 35 • Up to 5 years
|
26.5%
13/49 • Number of events 44 • Up to 5 years
|
23.7%
23/97 • Number of events 93 • Up to 5 years
|
|
Gastrointestinal disorders
Ascites
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
4.1%
3/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
4.1%
4/97 • Number of events 12 • Up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
10.8%
8/74 • Number of events 26 • Up to 5 years
|
8.2%
4/49 • Number of events 11 • Up to 5 years
|
9.3%
9/97 • Number of events 14 • Up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
56.8%
42/74 • Number of events 308 • Up to 5 years
|
71.4%
35/49 • Number of events 206 • Up to 5 years
|
67.0%
65/97 • Number of events 664 • Up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 5 • Up to 5 years
|
7.2%
7/97 • Number of events 41 • Up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
4/74 • Number of events 5 • Up to 5 years
|
4.1%
2/49 • Number of events 2 • Up to 5 years
|
7.2%
7/97 • Number of events 30 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
3/74 • Number of events 4 • Up to 5 years
|
6.1%
3/49 • Number of events 5 • Up to 5 years
|
5.2%
5/97 • Number of events 49 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
3.1%
3/97 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.1%
3/74 • Number of events 5 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
4.1%
4/97 • Number of events 12 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
5.4%
4/74 • Number of events 4 • Up to 5 years
|
4.1%
2/49 • Number of events 4 • Up to 5 years
|
9.3%
9/97 • Number of events 56 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroparesis
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.4%
1/74 • Number of events 3 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
8.1%
6/74 • Number of events 12 • Up to 5 years
|
10.2%
5/49 • Number of events 10 • Up to 5 years
|
10.3%
10/97 • Number of events 17 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
37/74 • Number of events 131 • Up to 5 years
|
57.1%
28/49 • Number of events 107 • Up to 5 years
|
73.2%
71/97 • Number of events 326 • Up to 5 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
3.1%
3/97 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.8%
5/74 • Number of events 7 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
5.2%
5/97 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Visceral arterial ischemia
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
10/74 • Number of events 31 • Up to 5 years
|
24.5%
12/49 • Number of events 21 • Up to 5 years
|
27.8%
27/97 • Number of events 53 • Up to 5 years
|
|
General disorders
Chills
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
6.1%
3/49 • Number of events 3 • Up to 5 years
|
4.1%
4/97 • Number of events 5 • Up to 5 years
|
|
General disorders
Edema face
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
2.1%
2/97 • Number of events 4 • Up to 5 years
|
|
General disorders
Edema limbs
|
6.8%
5/74 • Number of events 28 • Up to 5 years
|
18.4%
9/49 • Number of events 25 • Up to 5 years
|
12.4%
12/97 • Number of events 46 • Up to 5 years
|
|
General disorders
Facial pain
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
General disorders
Fatigue
|
78.4%
58/74 • Number of events 370 • Up to 5 years
|
85.7%
42/49 • Number of events 292 • Up to 5 years
|
82.5%
80/97 • Number of events 786 • Up to 5 years
|
|
General disorders
Fever
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
3.1%
3/97 • Number of events 3 • Up to 5 years
|
|
General disorders
Flu like symptoms
|
4.1%
3/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
2.1%
2/97 • Number of events 3 • Up to 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
6.2%
6/97 • Number of events 10 • Up to 5 years
|
|
General disorders
Localized edema
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.7%
2/74 • Number of events 3 • Up to 5 years
|
4.1%
2/49 • Number of events 2 • Up to 5 years
|
7.2%
7/97 • Number of events 14 • Up to 5 years
|
|
General disorders
Pain
|
5.4%
4/74 • Number of events 25 • Up to 5 years
|
16.3%
8/49 • Number of events 12 • Up to 5 years
|
7.2%
7/97 • Number of events 10 • Up to 5 years
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 8 • Up to 5 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Eye infection
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Infections and infestations
Gum infection
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/74 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Infections and infestations
Kidney infection
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Infections and infestations
Lip infection
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Lung infection
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 5 • Up to 5 years
|
|
Infections and infestations
Sinusitis
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Skin infection
|
2.7%
2/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
6.2%
6/97 • Number of events 18 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
8.2%
4/49 • Number of events 4 • Up to 5 years
|
5.2%
5/97 • Number of events 6 • Up to 5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
7.2%
7/97 • Number of events 29 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
4/74 • Number of events 4 • Up to 5 years
|
6.1%
3/49 • Number of events 3 • Up to 5 years
|
4.1%
4/97 • Number of events 5 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 7 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
33.8%
25/74 • Number of events 97 • Up to 5 years
|
55.1%
27/49 • Number of events 130 • Up to 5 years
|
55.7%
54/97 • Number of events 167 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
18.9%
14/74 • Number of events 49 • Up to 5 years
|
26.5%
13/49 • Number of events 51 • Up to 5 years
|
14.4%
14/97 • Number of events 29 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
35.1%
26/74 • Number of events 102 • Up to 5 years
|
57.1%
28/49 • Number of events 129 • Up to 5 years
|
62.9%
61/97 • Number of events 229 • Up to 5 years
|
|
Investigations
Blood bilirubin increased
|
20.3%
15/74 • Number of events 58 • Up to 5 years
|
36.7%
18/49 • Number of events 91 • Up to 5 years
|
28.9%
28/97 • Number of events 103 • Up to 5 years
|
|
Investigations
Creatinine increased
|
8.1%
6/74 • Number of events 15 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
8.2%
8/97 • Number of events 14 • Up to 5 years
|
|
Investigations
INR increased
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 6 • Up to 5 years
|
|
Investigations
Investigations - Other, specify
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 11 • Up to 5 years
|
3.1%
3/97 • Number of events 34 • Up to 5 years
|
|
Investigations
Lipase increased
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
3.1%
3/97 • Number of events 16 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
8.1%
6/74 • Number of events 46 • Up to 5 years
|
12.2%
6/49 • Number of events 18 • Up to 5 years
|
13.4%
13/97 • Number of events 64 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
4.1%
3/74 • Number of events 5 • Up to 5 years
|
24.5%
12/49 • Number of events 46 • Up to 5 years
|
30.9%
30/97 • Number of events 134 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
6.8%
5/74 • Number of events 12 • Up to 5 years
|
18.4%
9/49 • Number of events 21 • Up to 5 years
|
21.6%
21/97 • Number of events 156 • Up to 5 years
|
|
Investigations
Serum amylase increased
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Investigations
Weight gain
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Investigations
Weight loss
|
9.5%
7/74 • Number of events 8 • Up to 5 years
|
16.3%
8/49 • Number of events 30 • Up to 5 years
|
18.6%
18/97 • Number of events 99 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
5.4%
4/74 • Number of events 23 • Up to 5 years
|
12.2%
6/49 • Number of events 28 • Up to 5 years
|
21.6%
21/97 • Number of events 133 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
12/74 • Number of events 30 • Up to 5 years
|
28.6%
14/49 • Number of events 37 • Up to 5 years
|
24.7%
24/97 • Number of events 56 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
4/74 • Number of events 4 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
8.2%
8/97 • Number of events 10 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.2%
12/74 • Number of events 72 • Up to 5 years
|
10.2%
5/49 • Number of events 23 • Up to 5 years
|
21.6%
21/97 • Number of events 63 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.1%
6/74 • Number of events 23 • Up to 5 years
|
8.2%
4/49 • Number of events 16 • Up to 5 years
|
9.3%
9/97 • Number of events 32 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.7%
2/74 • Number of events 4 • Up to 5 years
|
2.0%
1/49 • Number of events 4 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
5.2%
5/97 • Number of events 9 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.8%
5/74 • Number of events 8 • Up to 5 years
|
12.2%
6/49 • Number of events 10 • Up to 5 years
|
12.4%
12/97 • Number of events 70 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.8%
5/74 • Number of events 13 • Up to 5 years
|
6.1%
3/49 • Number of events 3 • Up to 5 years
|
5.2%
5/97 • Number of events 30 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.1%
3/74 • Number of events 10 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
4.1%
4/97 • Number of events 4 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
4/74 • Number of events 6 • Up to 5 years
|
4.1%
2/49 • Number of events 4 • Up to 5 years
|
7.2%
7/97 • Number of events 19 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
7/74 • Number of events 30 • Up to 5 years
|
8.2%
4/49 • Number of events 17 • Up to 5 years
|
11.3%
11/97 • Number of events 49 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
3/74 • Number of events 3 • Up to 5 years
|
12.2%
6/49 • Number of events 22 • Up to 5 years
|
8.2%
8/97 • Number of events 13 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.4%
4/74 • Number of events 14 • Up to 5 years
|
8.2%
4/49 • Number of events 19 • Up to 5 years
|
7.2%
7/97 • Number of events 12 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
2.7%
2/74 • Number of events 13 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
2.1%
2/97 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
2/74 • Number of events 20 • Up to 5 years
|
6.1%
3/49 • Number of events 11 • Up to 5 years
|
2.1%
2/97 • Number of events 31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
10/74 • Number of events 32 • Up to 5 years
|
12.2%
6/49 • Number of events 20 • Up to 5 years
|
7.2%
7/97 • Number of events 31 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
3/74 • Number of events 16 • Up to 5 years
|
6.1%
3/49 • Number of events 3 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.4%
4/74 • Number of events 16 • Up to 5 years
|
6.1%
3/49 • Number of events 6 • Up to 5 years
|
3.1%
3/97 • Number of events 5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.8%
5/74 • Number of events 11 • Up to 5 years
|
10.2%
5/49 • Number of events 12 • Up to 5 years
|
7.2%
7/97 • Number of events 20 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.7%
2/74 • Number of events 3 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.7%
2/74 • Number of events 13 • Up to 5 years
|
4.1%
2/49 • Number of events 4 • Up to 5 years
|
3.1%
3/97 • Number of events 5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
4/74 • Number of events 21 • Up to 5 years
|
6.1%
3/49 • Number of events 8 • Up to 5 years
|
7.2%
7/97 • Number of events 13 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 10 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
3/74 • Number of events 6 • Up to 5 years
|
10.2%
5/49 • Number of events 17 • Up to 5 years
|
7.2%
7/97 • Number of events 64 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia second to oncology chemo
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 7 • Up to 5 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
8.1%
6/74 • Number of events 27 • Up to 5 years
|
10.2%
5/49 • Number of events 15 • Up to 5 years
|
12.4%
12/97 • Number of events 23 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 8 • Up to 5 years
|
14.4%
14/97 • Number of events 84 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
9.5%
7/74 • Number of events 32 • Up to 5 years
|
12.2%
6/49 • Number of events 17 • Up to 5 years
|
19.6%
19/97 • Number of events 47 • Up to 5 years
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Lethargy
|
1.4%
1/74 • Number of events 16 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 8 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.1%
6/74 • Number of events 8 • Up to 5 years
|
2.0%
1/49 • Number of events 8 • Up to 5 years
|
2.1%
2/97 • Number of events 12 • Up to 5 years
|
|
Nervous system disorders
Presyncope
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 4 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Somnolence
|
1.4%
1/74 • Number of events 22 • Up to 5 years
|
2.0%
1/49 • Number of events 8 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 2 • Up to 5 years
|
2.1%
2/97 • Number of events 4 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Tremor
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
5.4%
4/74 • Number of events 15 • Up to 5 years
|
6.1%
3/49 • Number of events 4 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
1.4%
1/74 • Number of events 21 • Up to 5 years
|
4.1%
2/49 • Number of events 9 • Up to 5 years
|
3.1%
3/97 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
2.7%
2/74 • Number of events 12 • Up to 5 years
|
2.0%
1/49 • Number of events 7 • Up to 5 years
|
4.1%
4/97 • Number of events 13 • Up to 5 years
|
|
Psychiatric disorders
Hallucinations
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
10.8%
8/74 • Number of events 31 • Up to 5 years
|
12.2%
6/49 • Number of events 25 • Up to 5 years
|
5.2%
5/97 • Number of events 35 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.4%
1/74 • Number of events 3 • Up to 5 years
|
2.0%
1/49 • Number of events 7 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
5.4%
4/74 • Number of events 6 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
8.2%
8/97 • Number of events 27 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
2.1%
2/97 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
Renal calculi
|
2.7%
2/74 • Number of events 4 • Up to 5 years
|
2.0%
1/49 • Number of events 4 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
2/74 • Number of events 28 • Up to 5 years
|
2.0%
1/49 • Number of events 3 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 9 • Up to 5 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.4%
1/74 • Number of events 8 • Up to 5 years
|
2.0%
1/49 • Number of events 4 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/74 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.1%
3/74 • Number of events 8 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
2.1%
2/97 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
3/74 • Number of events 4 • Up to 5 years
|
8.2%
4/49 • Number of events 16 • Up to 5 years
|
8.2%
8/97 • Number of events 38 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
3/74 • Number of events 4 • Up to 5 years
|
8.2%
4/49 • Number of events 16 • Up to 5 years
|
17.5%
17/97 • Number of events 54 • Up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.7%
2/74 • Number of events 2 • Up to 5 years
|
4.1%
2/49 • Number of events 3 • Up to 5 years
|
3.1%
3/97 • Number of events 5 • Up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/74 • Number of events 2 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/74 • Up to 5 years
|
2.0%
1/49 • Number of events 1 • Up to 5 years
|
0.00%
0/97 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
17.6%
13/74 • Number of events 90 • Up to 5 years
|
24.5%
12/49 • Number of events 28 • Up to 5 years
|
17.5%
17/97 • Number of events 67 • Up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.7%
2/74 • Number of events 7 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.4%
1/74 • Number of events 1 • Up to 5 years
|
0.00%
0/49 • Up to 5 years
|
1.0%
1/97 • Number of events 1 • Up to 5 years
|
Additional Information
Emily Bergsland, M.D.
UCSF Helen Diller Family Comprehensive Cancer Center
Phone: 415-353-9888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60