Trial Outcomes & Findings for Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab (NCT NCT00724971)
NCT ID: NCT00724971
Last Updated: 2019-03-15
Results Overview
A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting \>=7 days, 4) Grade 4 thrombocytopenia lasting \>=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade \<=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose \>2 weeks
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2019-03-15
Participant Flow
Six consecutive patients were enrolled as the first cohort. The dose and administration were considered to be reasonable if \<=2 participants in the first cohort experienced a dose limiting toxicity (DLT), and an additional 4 subjects were to be enrolled as the expanded cohort for a total 10 participants.
Participant milestones
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Baseline characteristics by cohort
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Age, Continuous
|
60.20 years
STANDARD_DEVIATION 10.96 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The first cohort was analyzed for DLT.
A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting \>=7 days, 4) Grade 4 thrombocytopenia lasting \>=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade \<=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose \>2 weeks
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=6 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Number of Participants With Dose-limiting Toxicities (DLT)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 8 cycles (1 cycle = 28 days)Population: The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor CT scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity.
Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or \>75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or \>=50% decrease in the SPD.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=8 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Number of Participants With Objective Response: Evaluable Population
Complete response (CR)
|
6 Participants
|
|
Number of Participants With Objective Response: Evaluable Population
Complete response unconfirmed (CRu)
|
1 Participants
|
|
Number of Participants With Objective Response: Evaluable Population
Partial response (PR)
|
0 Participants
|
|
Number of Participants With Objective Response: Evaluable Population
Objective Response (CR+CRu+PR)
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 8 cycles (1 cycle = 28 days)Population: The ITT population included all participants who were enrolled in the intended dose scheme.
Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or \>75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or \>=50% decrease in the SPD.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Number of Participants With Objective Response: Intent-to-treat (ITT) Population
Complete response (CR)
|
6 Participants
|
|
Number of Participants With Objective Response: Intent-to-treat (ITT) Population
Complete response unconfirmed (CRu)
|
1 Participants
|
|
Number of Participants With Objective Response: Intent-to-treat (ITT) Population
Partial response (PR)
|
1 Participants
|
|
Number of Participants With Objective Response: Intent-to-treat (ITT) Population
Objective Response (CR+CRu+PR)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 591 daysPopulation: The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor computed tomography (CT) scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity.
The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by \>=50% in the size.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=8 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Progression-Free Survival (PFS)
|
NA weeks
The number of event (PD or death) was not sufficient to estimate the median PFS.
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OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Phamacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
CMC-544: Cycle 1
|
559 ng/mL
Standard Deviation 136
|
|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
CMC-544: Cycle 2
|
822 ng/mL
Standard Deviation 152
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|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
CMC-544: Cycle 3
|
958 ng/mL
Standard Deviation 64.0
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|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
Total Calicheamicin: Cycle 1
|
67.7 ng/mL
Standard Deviation 14.9
|
|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
Total Calicheamicin: Cycle 2
|
80.2 ng/mL
Standard Deviation 11.3
|
|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
Total Calicheamicin: Cycle 3
|
96.6 ng/mL
Standard Deviation 2.89
|
|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
G544: Cycle 1
|
839 ng/mL
Standard Deviation 157
|
|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
G544: Cycle 2
|
1110 ng/mL
Standard Deviation 88.9
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|
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
G544: Cycle 3
|
1210 ng/mL
Standard Deviation 177
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
The time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 2
|
29.08 hours
Standard Deviation 21.79
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 3
|
51.70 hours
Standard Deviation 20.59
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 1
|
61.23 hours
Standard Deviation 34.84
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 2
|
96.44 hours
Standard Deviation 31.31
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 3
|
167.87 hours
Standard Deviation 72.85
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 1
|
67.14 hours
Standard Deviation 31.84
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 2
|
101.59 hours
Standard Deviation 34.08
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 3
|
127.57 hours
Standard Deviation 32.76
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|
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 1
|
18.77 hours
Standard Deviation 1.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
AUClast= Area under the serum concentration versus time curve from time zero (pre-dose) to time of last measured concentration.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
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|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 1
|
12300 ng*hour/mL
Standard Deviation 6200
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 2
|
27000 ng*hour/mL
Standard Deviation 7450
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|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 3
|
50100 ng*hour/mL
Standard Deviation 6390
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 1
|
2850 ng*hour/mL
Standard Deviation 1400
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 2
|
6490 ng*hour/mL
Standard Deviation 2250
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|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 3
|
10700 ng*hour/mL
Standard Deviation 4750
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 1
|
38400 ng*hour/mL
Standard Deviation 16300
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|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 2
|
84900 ng*hour/mL
Standard Deviation 23400
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 3
|
127000 ng*hour/mL
Standard Deviation 44800
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
AUC∞ = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 1
|
22300 ng*hour/mL
Standard Deviation 2850
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 2
|
34800 ng*hour/mL
Standard Deviation 12200
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 3
|
54800 ng*hour/mL
Standard Deviation 7070
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 1
|
4060 ng*hour/mL
Standard Deviation 1100
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 2
|
7460 ng*hour/mL
Standard Deviation 2540
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 3
|
12700 ng*hour/mL
Standard Deviation 5400
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 1
|
47700 ng*hour/mL
Standard Deviation 14300
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 2
|
92300 ng*hour/mL
Standard Deviation 26300
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 3
|
138000 ng*hour/mL
Standard Deviation 42600
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
The rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 1
|
0.120 L/hour
Standard Deviation 0.0185
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 2
|
0.0782 L/hour
Standard Deviation 0.0192
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 3
|
0.0499 L/hour
Standard Deviation 0.0012
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 1
|
0.746 L/hour
Standard Deviation 0.212
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 3
|
0.249 L/hour
Standard Deviation 0.0686
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 1
|
0.0662 L/hour
Standard Deviation 0.0236
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 2
|
0.0331 L/hour
Standard Deviation 0.0077
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 3
|
0.0213 L/hour
Standard Deviation 0.0062
|
|
Clearance (CL) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 2
|
0.424 L/hour
Standard Deviation 0.133
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544Population: Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 1
|
2.33 L
Standard Deviation 0.0763
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 2
|
2.26 L
Standard Deviation 1.74
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
CMC-544: Cycle 3
|
3.02 L
Standard Deviation 1.23
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 1
|
47.6 L
Standard Deviation 11.3
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 2
|
45.6 L
Standard Deviation 7.04
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
Total Calicheamicin: Cycle 3
|
47.8 L
Standard Deviation 6.62
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 1
|
3.95 L
Standard Deviation 0.921
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 2
|
3.39 L
Standard Deviation 0.515
|
|
Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
G544: Cycle 3
|
3.02 L
Standard Deviation 0.400
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 Cycles (1 cycle = 28 days)Population: The intent-to-treat (ITT) population included all participants in the intended dose scheme.
Antibody responses to CMC-544
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544)
Screening
|
1 Participants
|
|
Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544)
End of Treatment
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 Cycles (1 cycle = 28 days)Population: The intent-to-treat (ITT) population included all participants in the intended dose scheme.
Antibody responses to rituximab
Outcome measures
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 Participants
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Number of Participants With Positive Serum Antibody to Rituximab
Screening
|
0 Participants
|
|
Number of Participants With Positive Serum Antibody to Rituximab
End of Treatment
|
0 Participants
|
Adverse Events
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2
n=10 participants at risk
Participants were treated with intravenous rituximab (375 mg/m\^2) followed by intravenous CMC-544 (1.8 mg/m\^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Erythropenia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
80.0%
8/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
60.0%
6/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Monocytosis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
70.0%
7/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
10/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Glossitis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
8/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Extravasation
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
50.0%
5/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
40.0%
4/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Cytokine release syndrome
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Food allergy
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis bacterial
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
80.0%
8/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
90.0%
9/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
5/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood amylase increased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood calcium increased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
60.0%
6/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium decreased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood sodium increased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glucose urine present
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haematocrit decreased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein total decreased
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
5/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
40.0%
4/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER